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A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers

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ClinicalTrials.gov Identifier: NCT01746901
Recruitment Status : Completed
First Posted : December 11, 2012
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Other
Condition Healthy
Interventions Drug: Placebo
Drug: intact ALO-02 60 mg/7.2 mg
Drug: crushed ALO-02 60 mg/7.2 mg
Drug: crushed oxycodone IR 60 mg
Drug: crushed ALO-02 40 mg/4.8 mg
Drug: crushed oxycodone IR 40 mg
Enrollment 81
Recruitment Details Recreational opioid users who were not dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria, were recruited in this study.
Pre-assignment Details After successful naloxone challenge test, all participants underwent training sessions involving complete pharmacodynamics test battery before the drug discrimination phase, to ensure that participants fully understood how to perform the tests, were comfortable, and attained a stable level of performance on the various performance-based measures.
Arm/Group Title Naloxone Oxycodone HCl 40 mg Then PBO PBO Then Oxycodone HCl 40 mg ALO-02 60 Mg-I,ALO-02 60 Mg-C,PBO,OXY 60,40 mg,ALO-02 40 Mg-C ALO-02 40 Mg-C,OXY 40,60 mg,PBO,ALO-02 60 Mg-C,ALO-02 60 Mg-I ALO-02 60 Mg-C,OXY 60 mg,ALO-02 60 Mg-I,40 Mg-C,PBO,OXY40 mg OXY 40 mg,PBO,ALO-02 40 Mg-C,60 Mg-I,OXY 60 mg,ALO-02 60 Mg-C OXY 60 mg,ALO-02 40, 60 Mg-C,OXY 40 mg,ALO-02 60 Mg-I,PBO PBO,ALO-02 60 Mg-I,OXY 40 mg, ALO-02 60, 40 Mg-C,OXY 60 mg
Hide Arm/Group Description Naloxone hydrochloride (HCl) 0.2 milligram (mg) intravenously followed by additional 0.6 mg naloxone hydrochloride intravenously on Day 0, each dose followed by an assessment for signs and symptoms of opioid withdrawal. Participants who did not display signs and symptoms of opioid withdrawal, were assigned to either oxycodone HCl 40 mg then placebo or placebo then oxycodone HCl 40 mg group in the drug discrimination phase of the study. Single dose of oxycodone HCl 40 mg crushed tablet in solution, orally on Day 1 followed by single dose of placebo matched to oxycodone HCl crushed tablet orally on Day 2. Participants were assigned to receive oxycodone HCl 60 mg and naltrexone HCl 7.2 mg extended-release (ALO-02) 60 mg/7.2 mg intact capsule, ALO-02 60 mg/7.2 mg and ALO-02 40 mg/4.8 mg crushed capsule in solution, oxycodone HCl 40 mg (OXY 40 mg) and 60 mg crushed tablet (OXY 60 mg) in solution, placebo matched to either ALO-02 intact (PBO) and crushed capsule or oxycodone crushed tablet (PBO), orally, in either of the 6 sequences in the treatment phase of the study. Single dose of placebo matched to oxycodone HCl crushed tablet orally on Day 1 followed by single dose of oxycodone HCl 40 mg crushed tablet in solution, orally on Day 2. Participants were assigned to receive oxycodone HCl 60 mg and naltrexone HCl 7.2 mg extended-release (ALO-02) 60 mg/7.2 mg intact capsule, ALO-02 60 mg/7.2 mg and ALO-02 40 mg/4.8 mg crushed capsule in solution, oxycodone HCl 40 mg (OXY 40 mg) and 60 mg crushed tablet (OXY 60 mg) in solution, placebo matched to either ALO-02 intact (PBO) and crushed capsule or oxycodone crushed tablet (PBO), orally, in either of the 6 sequences in the treatment phase of the study. Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in first intervention period; followed by single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in second intervention period; then single dose of matching placebo (PBO) orally on Day 1 in third intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in fourth intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period. Single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in first intervention period; followed by single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on orally on Day 1 in second intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in third intervention period; then single dose of matching placebo (PBO) orally on Day 1 in fourth intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period. Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in first intervention period; followed by single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in second intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in third intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in fourth intervention period; then single dose of matching placebo (PBO) orally on Day 1 in fifth intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period. Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in first intervention period; followed by single dose of matching placebo (PBO) orally on Day 1 in second intervention period; then single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in third intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in fourth intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in fifth intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period. Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in first intervention period; followed by single dose of ALO-02 40mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally on Day 1 in second intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in third intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in fourth intervention period; then single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in fifth intervention period; then by single dose of matching placebo (PBO) orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period. Single dose of matching placebo (PBO) orally on Day 1 in first intervention period; followed by single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally on Day 1 in second intervention period; then single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally on Day 1 in third intervention period; then single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally on Day 1 in fourth intervention period; then single dose of ALO-02 40 mg/4.8 mg crushed capsule (ALO-02 40 mg-I) solution orally on Day 1 in fifth intervention period; then single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally on Day 1 in sixth intervention period. A washout period of at least 5 days (not exceeding 14 days) was maintained between each intervention period.
Period Title: Naloxone Challenge Phase
Started 75 0 0 0 0 0 0 0 0
Completed 72 0 0 0 0 0 0 0 0
Not Completed 3 0 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             2             0             0             0             0             0             0             0             0
Did not meet entrance criteria             1             0             0             0             0             0             0             0             0
Period Title: Drug Discrimination Phase: Day 1
Started 0 36 36 0 0 0 0 0 0
Completed 0 33 36 0 0 0 0 0 0
Not Completed 0 3 0 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             3             0             0             0             0             0             0             0
Period Title: Drug Discrimination Phase: Day 2
Started 0 33 36 0 0 0 0 0 0
Completed 0 19 22 0 0 0 0 0 0
Not Completed 0 14 14 0 0 0 0 0 0
Reason Not Completed
Adverse Event             0             2             1             0             0             0             0             0             0
Did not met entrance criteria             0             9             10             0             0             0             0             0             0
Protocol Violation             0             3             3             0             0             0             0             0             0
Period Title: Treatment Phase: First Intervention
Started 0 0 0 6 6 7 8 7 7
Completed 0 0 0 6 6 7 7 7 7
Not Completed 0 0 0 0 0 0 1 0 0
Reason Not Completed
Protocol Violation             0             0             0             0             0             0             1             0             0
Period Title: Treatment Phase: Washout Period 1
Started 0 0 0 6 6 7 7 7 7
Completed 0 0 0 6 6 7 7 7 7
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Treatment Phase: Second Intervention
Started 0 0 0 6 6 7 7 7 7
Completed 0 0 0 6 6 7 7 6 7
Not Completed 0 0 0 0 0 0 0 1 0
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             0             0             1             0
Period Title: Treatment Phase: Washout Period 2
Started 0 0 0 6 6 7 7 6 7
Completed 0 0 0 6 6 7 7 6 7
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Treatment Phase: Third Intervention
Started 0 0 0 6 6 7 7 6 7
Completed 0 0 0 6 6 6 6 6 7
Not Completed 0 0 0 0 0 1 1 0 0
Reason Not Completed
Protocol Violation             0             0             0             0             0             1             1             0             0
Period Title: Treatment Phase: Washout Period 3
Started 0 0 0 6 6 6 6 6 7
Completed 0 0 0 6 6 6 6 6 7
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Treatment Phase: Fourth Intervention
Started 0 0 0 6 6 6 6 6 7
Completed 0 0 0 5 6 5 5 6 5
Not Completed 0 0 0 1 0 1 1 0 2
Reason Not Completed
Lost to Follow-up             0             0             0             1             0             0             0             0             0
Adverse Event             0             0             0             0             0             1             0             0             1
Protocol Violation             0             0             0             0             0             0             1             0             1
Period Title: Treatment Phase: Washout Period 4
Started 0 0 0 5 6 5 5 6 5
Completed 0 0 0 5 6 5 5 6 5
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Treatment Phase: Fifth Intervention
Started 0 0 0 5 6 5 5 6 5
Completed 0 0 0 5 6 5 5 6 5
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Treatment Phase: Washout Period 5
Started 0 0 0 5 6 5 5 6 5
Completed 0 0 0 5 6 5 5 6 5
Not Completed 0 0 0 0 0 0 0 0 0
Period Title: Treatment Phase: Sixth Intervention
Started 0 0 0 5 6 5 5 6 5
Completed 0 0 0 5 6 5 5 6 5
Not Completed 0 0 0 0 0 0 0 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Included all participants enrolled in the study.
Overall Number of Baseline Participants 75
Hide Baseline Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants
38.6  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants
Female
18
  24.0%
Male
57
  76.0%
1.Primary Outcome
Title Drug Liking: Peak Effect (Emax)
Hide Description Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). Peak Effect (Emax) = Maximum observed score.
Time Frame 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose Pharmacodynamic (PD) data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: mm
51.6  (3.74) 70.1  (19.23) 85.5  (16.11) 59.3  (15.09) 74.4  (18.10) 89.7  (13.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value 30.5
Confidence Interval (2-Sided) 95%
24.4 to 36.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0132
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 7.7
Confidence Interval (2-Sided) 95%
1.6 to 13.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 15.3
Confidence Interval (2-Sided) 95%
9.3 to 21.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 22.9
Confidence Interval (2-Sided) 95%
16.8 to 28.9
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 15.3
Confidence Interval (2-Sided) 95%
9.3 to 21.4
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 18.5
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 18.5
Confidence Interval (2-Sided) 95%
12.5 to 24.6
Estimation Comments [Not Specified]
2.Primary Outcome
Title Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour
Hide Description Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment). It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
Time Frame 0.25, 0.5, 1, 1.5, 2 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: hours*mm
100.004  (5.1468) 118.480  (28.7707) 141.305  (32.9203) 100.188  (10.6437) 127.320  (31.2906) 149.484  (24.1907)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 49.3
Confidence Interval (2-Sided) 95%
39.2 to 59.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9994
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-10.1 to 10.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 22.2
Confidence Interval (2-Sided) 95%
12.1 to 32.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 27.1
Confidence Interval (2-Sided) 95%
17.0 to 37.3
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 23.0
Confidence Interval (2-Sided) 95%
12.8 to 33.1
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 18.2
Confidence Interval (2-Sided) 95%
8.1 to 28.4
Estimation Comments [Not Specified]
3.Primary Outcome
Title High: Peak Effect (Emax)
Hide Description High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time Frame 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose in treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: mm
10.9  (20.60) 47.3  (36.88) 77.9  (25.46) 21.7  (35.36) 53.4  (34.68) 84.7  (23.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 63.2
Confidence Interval (2-Sided) 95%
51.5 to 74.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0402
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 12.3
Confidence Interval (2-Sided) 95%
0.6 to 24.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 32.9
Confidence Interval (2-Sided) 95%
21.1 to 44.7
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 42.6
Confidence Interval (2-Sided) 95%
30.9 to 54.4
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 32.1
Confidence Interval (2-Sided) 95%
20.3 to 43.9
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 36.3
Confidence Interval (2-Sided) 95%
24.6 to 48.1
Estimation Comments [Not Specified]
4.Primary Outcome
Title High: Area Under Effect Curve (AUE) From 0-2 Hour
Hide Description High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
Time Frame pre-dose, 0.25, 0.5, 1, 1.5, 2 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: hours*mm
2.496  (8.3003) 55.250  (54.1280) 112.082  (43.7000) 9.902  (21.1911) 71.254  (55.9812) 117.578  (42.2152)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 108.0
Confidence Interval (2-Sided) 95%
91.6 to 124.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4125
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 6.8
Confidence Interval (2-Sided) 95%
-9.6 to 23.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 46.1
Confidence Interval (2-Sided) 95%
29.6 to 62.5
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 68.8
Confidence Interval (2-Sided) 95%
52.4 to 85.2
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 56.7
Confidence Interval (2-Sided) 95%
40.3 to 73.2
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 52.6
Confidence Interval (2-Sided) 95%
36.2 to 69.0
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Take Drug Again: Peak Effect (Emax)
Hide Description Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = “definitely would not”, 50 mm = “do not care”, and 100 mm = “definitely would”). Emax = Maximum observed score.
Time Frame 12, 24, 36 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: mm
45.7  (19.05) 57.9  (33.58) 83.4  (20.26) 48.1  (28.14) 72.0  (28.31) 81.3  (25.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 32.8
Confidence Interval (2-Sided) 95%
21.8 to 43.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6434
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
-8.4 to 13.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1072
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 9.0
Confidence Interval (2-Sided) 95%
-2.0 to 20.0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 26.3
Confidence Interval (2-Sided) 95%
15.4 to 37.3
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 25.7
Confidence Interval (2-Sided) 95%
14.7 to 36.6
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0335
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
0.9 to 22.9
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Take Drug Again: Mean Effect (Emean)
Hide Description Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = “definitely would not”, 50 mm = “do not care”, and 100 mm = “definitely would”). Emax = Maximum observed score.
Time Frame 12, 24, 36 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: mm
42.90  (20.002) 54.71  (32.635) 77.80  (22.880) 42.63  (26.293) 68.78  (29.883) 78.02  (24.868)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 35.0
Confidence Interval (2-Sided) 95%
24.0 to 46.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9811
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-11.1 to 10.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1083
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 9.0
Confidence Interval (2-Sided) 95%
-2.0 to 19.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 25.9
Confidence Interval (2-Sided) 95%
14.9 to 36.9
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 23.2
Confidence Interval (2-Sided) 95%
12.3 to 34.2
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0408
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 11.5
Confidence Interval (2-Sided) 95%
0.5 to 22.4
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Take Drug Again: Minimum Effect (Emin)
Hide Description Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = “definitely would not”, 50 mm = “do not care”, and 100 mm = “definitely would”). Emax = Maximum observed score.
Time Frame 12, 24, 36 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: mm
41.1  (21.60) 50.9  (32.46) 73.2  (26.92) 37.8  (28.72) 66.3  (31.57) 75.2  (24.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 36.9
Confidence Interval (2-Sided) 95%
25.2 to 48.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5968
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-14.9 to 8.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1471
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 8.7
Confidence Interval (2-Sided) 95%
-3.1 to 20.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1136
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 9.5
Confidence Interval (2-Sided) 95%
-2.3 to 21.3
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 22.4
Confidence Interval (2-Sided) 95%
10.6 to 34.2
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1136
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 9.5
Confidence Interval (2-Sided) 95%
-2.3 to 21.3
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Take Drug Again Effect at Hours 12, 24 and 36
Hide Description Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity. It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = “definitely would not”, 50 mm = “do not care”, and 100 mm = “definitely would”). Emax = Maximum observed score.
Time Frame 12, 24, 36 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: mm
Hour 12 44.0  (20.63) 54.7  (33.56) 79.7  (22.37) 45.8  (27.53) 68.7  (30.31) 78.9  (25.21)
Hour 24 41.8  (21.79) 55.5  (32.73) 76.9  (26.77) 41.0  (28.73) 69.6  (28.34) 78.3  (25.17)
Hour 36 42.9  (20.40) 53.9  (32.84) 76.8  (25.12) 41.1  (28.95) 68.1  (31.99) 76.8  (25.17)
9.Secondary Outcome
Title Overall Drug Liking: Peak Effect (Emax)
Hide Description Overall drug liking VAS assesses the participant’s global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = “strong disliking”, 50 mm = “neither like nor dislike”, and 100 mm= “strong liking”). Emax = Maximum observed score.
Time Frame 12, 24, 36 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: mm
50.8  (12.80) 64.3  (24.00) 80.8  (19.51) 52.9  (21.33) 74.0  (22.44) 81.6  (23.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 28.5
Confidence Interval (2-Sided) 95%
19.6 to 37.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6209
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.2
Confidence Interval (2-Sided) 95%
-6.7 to 11.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0997
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 7.5
Confidence Interval (2-Sided) 95%
-1.4 to 16.3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 23.2
Confidence Interval (2-Sided) 95%
14.4 to 32.1
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 16.6
Confidence Interval (2-Sided) 95%
7.7 to 25.5
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0036
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 13.3
Confidence Interval (2-Sided) 95%
4.4 to 22.2
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Overall Drug Liking: Mean Effect (Emean)
Hide Description Overall drug liking VAS assesses the participant’s global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = “strong disliking”, 50 mm = “neither like nor dislike”, and 100 mm= “strong liking”). Emean = Average observed score.
Time Frame 12, 24, 36 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: mm
50.19  (11.962) 61.26  (24.489) 75.70  (21.304) 47.72  (20.715) 69.94  (23.370) 77.90  (23.077)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 29.9
Confidence Interval (2-Sided) 95%
21.1 to 38.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5951
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-11.2 to 6.4
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0841
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 7.8
Confidence Interval (2-Sided) 95%
-1.1 to 16.6
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 19.8
Confidence Interval (2-Sided) 95%
11.0 to 28.6
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 14.5
Confidence Interval (2-Sided) 95%
5.7 to 23.4
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0172
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
1.9 to 19.6
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Overall Drug Liking: Minimum Effect (Emin)
Hide Description Overall drug liking VAS assesses the participant’s global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = “strong disliking”, 50 mm = “neither like nor dislike”, and 100 mm= “strong liking”). Emin= Average observed score.
Time Frame 12, 24, 36 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: mm
49.6  (11.40) 58.5  (24.82) 71.1  (25.28) 43.6  (23.55) 65.6  (25.87) 74.3  (23.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 30.4
Confidence Interval (2-Sided) 95%
21.0 to 39.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2166
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -5.9
Confidence Interval (2-Sided) 95%
-15.4 to 3.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0777
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 8.5
Confidence Interval (2-Sided) 95%
-1.0 to 18.0
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 16.0
Confidence Interval (2-Sided) 95%
6.5 to 25.4
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0086
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 12.7
Confidence Interval (2-Sided) 95%
3.3 to 22.2
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0775
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 8.5
Confidence Interval (2-Sided) 95%
-0.9 to 18.0
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Overall Drug Liking Effect at Hours 12, 24 and 36
Hide Description Overall drug liking VAS assesses the participant’s global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects). A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = “strong disliking”, 50 mm = “neither like nor dislike”, and 100 mm= “strong liking”).
Time Frame 12, 24, 36 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: mm
Hour 12 50.6  (12.78) 61.2  (26.16) 78.5  (20.86) 51.8  (21.57) 69.8  (23.19) 78.1  (23.99)
Hour 24 50.3  (11.84) 62.7  (23.25) 75.5  (24.26) 44.8  (23.62) 70.1  (24.53) 78.1  (22.95)
Hour 36 49.7  (11.41) 59.9  (25.20) 73.2  (25.03) 46.6  (23.35) 69.9  (25.43) 77.6  (23.79)
13.Secondary Outcome
Title Any Drug Effects: Peak Effect (Emax)
Hide Description Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). Emax = Maximum observed score.
Time Frame 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: mm
8.8  (19.43) 47.2  (38.45) 82.4  (25.27) 27.7  (35.77) 56.0  (35.90) 88.7  (20.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 61.2
Confidence Interval (2-Sided) 95%
48.8 to 73.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0032
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 18.8
Confidence Interval (2-Sided) 95%
6.4 to 31.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 32.9
Confidence Interval (2-Sided) 95%
20.5 to 45.3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 47.2
Confidence Interval (2-Sided) 95%
34.8 to 59.6
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 73.6
Confidence Interval (2-Sided) 95%
61.1 to 86.0
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 38.4
Confidence Interval (2-Sided) 95%
26.0 to 50.8
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour, 0-12 Hour, 0-24 Hour and 0-36 Hour
Hide Description Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm). AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
Time Frame 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 14, 24, 36 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Completer analysis set included all randomized participants who completed all 6 periods of treatment phase and who contributed to post-dose PD data from each period.
Arm/Group Title Placebo ALO-02 40 Mg-C OXY 40 mg ALO-02 60 Mg-I ALO-02 60 mg- C OXY 60 mg
Hide Arm/Group Description:
Single dose of matching placebo solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 40 mg/4.8 mg crushed tablet (ALO-02 40 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 40 mg (OXY 40 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg intact capsule (ALO-02 60 mg-I) solution orally in either of the first to sixth intervention periods.
Single dose of ALO-02 60 mg/7.2 mg crushed capsule (ALO-02 60 mg-C) solution orally in either of the first to sixth intervention periods.
Single dose of oxycodone HCl 60 mg (OXY 60 mg) crushed tablet solution orally in either of the first to sixth intervention periods.
Overall Number of Participants Analyzed 32 32 32 32 32 32
Mean (Standard Deviation)
Unit of Measure: hours*mm
AUE (0-1) 1.105  (5.6058) 20.129  (23.9971) 40.199  (20.3489) 4.539  (11.9639) 26.566  (24.8693) 48.328  (19.8494)
AUE (0-2) 3.090  (10.1113) 57.504  (57.6543) 112.910  (41.6661) 10.734  (23.0043) 69.059  (55.0442) 124.617  (41.2197)
AUE (0-8) 5.949  (16.4695) 140.152  (147.5551) 283.770  (173.4241) 53.242  (99.4186) 167.137  (152.8249) 354.391  (184.4799)
AUE (0-12) 5.949  (16.4695) 156.652  (175.1035) 317.270  (218.4262) 107.180  (190.7655) 176.199  (165.0887) 392.828  (229.3565)
AUE (0-24) 13.762  (46.7425) 157.059  (175.7028) 345.301  (260.4659) 218.805  (379.7129) 184.137  (172.7494) 402.516  (244.3471)
AUE (0-36) 23.324  (98.1331) 157.059  (175.7028) 345.488  (260.3746) 235.117  (424.9088) 186.387  (173.5877) 402.703  (244.2750)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 43.9
Confidence Interval (2-Sided) 95%
36.0 to 51.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4154
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.3
Confidence Interval (2-Sided) 95%
-4.6 to 11.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 21.8
Confidence Interval (2-Sided) 95%
13.9 to 29.7
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 25.4
Confidence Interval (2-Sided) 95%
17.5 to 33.3
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 20.2
Confidence Interval (2-Sided) 95%
12.3 to 28.1
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments AUE (0-1): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 18.9
Confidence Interval (2-Sided) 95%
11.0 to 26.8
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 114.2
Confidence Interval (2-Sided) 95%
97.1 to 131.3
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3985
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 7.3
Confidence Interval (2-Sided) 95%
-9.8 to 24.4
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 55.6
Confidence Interval (2-Sided) 95%
38.5 to 72.8
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 65.9
Confidence Interval (2-Sided) 95%
48.8 to 83.0
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 55.6
Confidence Interval (2-Sided) 95%
38.5 to 72.7
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments AUE (0-2): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 54.1
Confidence Interval (2-Sided) 95%
37.0 to 71.2
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 302.8
Confidence Interval (2-Sided) 95%
248.8 to 356.8
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0824
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 47.8
Confidence Interval (2-Sided) 95%
-6.2 to 101.7
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 188.5
Confidence Interval (2-Sided) 95%
134.6 to 242.5
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 162.0
Confidence Interval (2-Sided) 95%
108.0 to 216.0
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 141.9
Confidence Interval (2-Sided) 95%
87.9 to 195.8
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments AUE (0-8): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 135.7
Confidence Interval (2-Sided) 95%
81.7 to 189.6
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 287.6
Confidence Interval (2-Sided) 95%
219.1 to 356.1
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0040
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 101.4
Confidence Interval (2-Sided) 95%
32.9 to 169.8
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 218.5
Confidence Interval (2-Sided) 95%
150.0 to 287.0
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 170.5
Confidence Interval (2-Sided) 95%
102.0 to 239.0
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 158.6
Confidence Interval (2-Sided) 95%
90.1 to 227.1
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments AUE (0-12): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 152.2
Confidence Interval (2-Sided) 95%
83.7 to 220.7
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 185.9
Confidence Interval (2-Sided) 95%
90.1 to 281.8
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 Mg-I
Comments AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 205.0
Confidence Interval (2-Sided) 95%
109.2 to 300.8
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection ALO-02 60 mg- C, OXY 60 mg
Comments AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 221.0
Confidence Interval (2-Sided) 95%
125.2 to 316.7
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 60 mg- C
Comments AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 170.0
Confidence Interval (2-Sided) 95%
74.1 to 265.8
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection ALO-02 40 Mg-C, OXY 40 mg
Comments AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 185.7
Confidence Interval (2-Sided) 95%
89.9 to 281.5
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo, ALO-02 40 Mg-C
Comments AUE (0-24): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0033
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 144.9
Confidence Interval (2-Sided) 95%
49.1 to 240.8
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection ALO-02 60 Mg-I, OXY 60 mg
Comments AUE (0-36): Mixed-effect model with treatment, period, and sequence as fixed effects, and participants nested within the sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]