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Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

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ClinicalTrials.gov Identifier: NCT01038609
Recruitment Status : Completed
First Posted : December 24, 2009
Results First Posted : March 7, 2014
Last Update Posted : April 8, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Hydrocodone/Acetaminophen Extended Release
Drug: Acetaminophen
Drug: Morphine Extended Release
Drug: Placebo
Enrollment 250

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acetaminophen Morphine Extended Release Morphine Extended Release / Acetaminophen Hydrocodone/Acetaminophen Extended Release Placebo
Hide Arm/Group Description 1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses). 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses). 1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses). 1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses). 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Period Title: Overall Study
Started 50 52 49 48 51
Completed 49 51 48 47 50
Not Completed 1 1 1 1 1
Reason Not Completed
Adverse Event             0             0             1             0             0
Dosing Error             0             0             0             1             1
Death in the Family             1             0             0             0             0
Refusal of Blood Draws             0             1             0             0             0
Arm/Group Title Acetaminophen Morphine Extended Release Morphine Extended Release / Acetaminophen Hydrocodone/Acetaminophen Extended Release Placebo Total
Hide Arm/Group Description 1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses). 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses). 1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses). 1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses). 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses). Total of all reporting groups
Overall Number of Baseline Participants 50 52 49 48 51 250
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 52 participants 49 participants 48 participants 51 participants 250 participants
44.9  (13.83) 44.0  (12.93) 40.2  (11.31) 40.4  (13.16) 45.2  (12.47) 43.0  (12.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 52 participants 49 participants 48 participants 51 participants 250 participants
Female
45
  90.0%
44
  84.6%
39
  79.6%
41
  85.4%
45
  88.2%
214
  85.6%
Male
5
  10.0%
8
  15.4%
10
  20.4%
7
  14.6%
6
  11.8%
36
  14.4%
1.Primary Outcome
Title Sum of Pain Intensity Difference (SPID) Using the Pain Intensity Visual Analogue Scale (VAS)
Hide Description Participants assessed pain intensity on a 100 mm visual analogue scale (VAS) with 0 meaning "no pain" and 100 meaning the "worst pain imaginable". The SPID VAS score for 0 to 48 hours following initial study drug dose measured the cumulative pain intensity difference during treatment with higher mean SPID VAS scores indicating greater improvement from Baseline. The SPID score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
Time Frame From time of first study drug administration to 48 hours following first study drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).
Arm/Group Title Acetaminophen Morphine Extended Release Morphine Extended Release / Acetaminophen Hydrocodone/Acetaminophen Extended Release Placebo
Hide Arm/Group Description:
1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Overall Number of Participants Analyzed 50 52 49 48 51
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
720.5  (154.89) 239.9  (151.41) 614.4  (156.92) 450.8  (159.62) -57.6  (153.99)
2.Secondary Outcome
Title TOTPAR (Total Pain Relief)
Hide Description TOTPAR was the time-interval weighted sum of pain relief. Pain relief was assessed by participants’ responses to how their pain relief was compared with the pain they had just before receiving the first dose of study drug: no relief, a little relief, some relief, a lot of relief, or complete relief. Higher mean TOTPAR scores indicate better pain relief. The TOTPAR score is a measure of the cumulative pain intensity difference during treatment and the area under the curve was estimated using the linear trapezoidal rule.
Time Frame From time of first study drug administration to 48 hours following first study drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).
Arm/Group Title Acetaminophen Morphine Extended Release Morphine Extended Release / Acetaminophen Hydrocodone/Acetaminophen Extended Release Placebo
Hide Arm/Group Description:
1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Overall Number of Participants Analyzed 50 52 49 48 51
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
65.9  (7.17) 42.7  (7.01) 49.5  (7.24) 56.3  (7.34) 32.9  (7.12)
3.Secondary Outcome
Title Participant's Global Assessment of Study Drug
Hide Description The participant's overall impression of the study drug was obtained on a 5-point categorical scale: excellent; very good; good; fair; poor.
Time Frame From time of first study drug administration to 48 hours following first study drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).
Arm/Group Title Acetaminophen Morphine Extended Release Morphine Extended Release / Acetaminophen Hydrocodone/Acetaminophen Extended Release Placebo
Hide Arm/Group Description:
1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Overall Number of Participants Analyzed 50 52 49 48 51
Measure Type: Number
Unit of Measure: participants
Excellent 9 8 4 7 3
Very Good 15 16 19 20 17
Good 16 14 12 15 12
Fair 10 3 11 4 15
Poor 0 11 3 2 4
4.Secondary Outcome
Title Time to Perceptible and Meaningful Pain Relief
Hide Description The median time (minutes) from first perceptible pain relief (onset of pain relief) and time until first meaningful pain relief.
Time Frame From time of first study drug administration to 12 hours following first study drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).
Arm/Group Title Acetaminophen Morphine Extended Release Morphine Extended Release / Acetaminophen Hydrocodone/Acetaminophen Extended Release Placebo
Hide Arm/Group Description:
1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Overall Number of Participants Analyzed 50 52 49 48 51
Median (95% Confidence Interval)
Unit of Measure: minutes
Time to Onset of Perceptible Pain Relief
25.5
(17.0 to 30.0)
32.0
(25.0 to 63.0)
31.0
(22.0 to 44.0)
22.5
(18.0 to 27.0)
23.0
(16.0 to 37.0)
Time to Onset of Meaningful Pain Relief
62.5
(46.0 to 90.0)
142.0 [1] 
(76.0 to NA)
101.0 [1] 
(53.0 to NA)
60.5
(49.0 to 83.0)
220.0 [1] 
(64.0 to NA)
[1]
not available from Kaplan-Meier estimate
5.Secondary Outcome
Title Participants With Adverse Events (AEs)
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.
Time Frame AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 32 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).
Arm/Group Title Acetaminophen Morphine Extended Release Morphine Extended Release / Acetaminophen Hydrocodone/Acetaminophen Extended Release Placebo
Hide Arm/Group Description:
1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Overall Number of Participants Analyzed 50 52 49 48 51
Measure Type: Number
Unit of Measure: participants
Any AE 28 29 28 33 28
Any AE at least "possibly" drug related 23 23 23 24 19
Any "severe" AE 1 1 2 5 1
Any SAE 0 0 0 0 0
Any AE leading to discontinuation of study drug 0 0 1 0 0
Any AE leading to death 0 0 0 0 0
Death 0 0 0 0 0
6.Secondary Outcome
Title Number of Participants With Vital Signs Values Meeting Potentially Clinically Significant Criteria
Hide Description Potentially clinically significant criteria: Systolic blood pressure (BP) ≤90 mm Hg and ≥20 mm Hg decrease (low) or ≥180 mm Hg and ≥20 mm Hg increase (high); Diastolic BP ≤50 mm Hg and ≥15 mm Hg decrease (low) or ≥105 mm Hg and ≥15 mm Hg increase (high). Heart rate ≤50 beats per minute (bpm) and ≥15 bpm decrease (low) or ≥120 bpm and ≥15 bpm increase (high). Respiratory rate <10 respirations per minute (rpm) (low) or >24 rpm (high).
Time Frame At specified intervals from Screening through 7 days after first dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).
Arm/Group Title Acetaminophen Morphine Extended Release Morphine Extended Release / Acetaminophen Hydrocodone/Acetaminophen Extended Release Placebo
Hide Arm/Group Description:
1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Overall Number of Participants Analyzed 50 52 49 48 51
Measure Type: Number
Unit of Measure: participants
Systolic BP decrease 3 6 8 2 5
Systolic BP increase 1 0 0 0 1
Diastolic BP decrease 2 5 6 5 2
Diastolic BP increase 0 0 2 0 0
Heart rate decrease 3 1 0 2 0
Heart rate increase 1 0 0 1 0
Respiratory rate < 10 rpm 0 0 0 0 0
Respiratory rate > 24 rpm 0 0 0 0 0
7.Secondary Outcome
Title Number of Participants With Chemistry Values Meeting Potentially Clinically Significant Criteria
Hide Description Potentially clinically significant criteria: alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≥3 times upper limit of normal (ULN); calcium ≤1.8 mmol/L.
Time Frame At specified intervals from Screening through 7 days after first dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug. Analyses were performed based on the treatment participants actually received (as-treated).
Arm/Group Title Acetaminophen Morphine Extended Release Morphine Extended Release / Acetaminophen Hydrocodone/Acetaminophen Extended Release Placebo
Hide Arm/Group Description:
1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
Overall Number of Participants Analyzed 50 52 49 48 51
Measure Type: Number
Unit of Measure: participants
ALT >= 3 * ULN 1 2 3 0 0
AST >= 3 * ULN 1 2 3 0 0
Calcium <= 1.8 mmol/L 0 0 1 0 2
Time Frame AEs were recorded from study drug administration until 30 days following discontinuation of study drug (total 32 days); SAEs were recorded from the time informed consent was obtained until 30 days following discontinuation of study drug (total 51 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetaminophen Morphine Extended Release Morphine Extended Release/Acetaminophen Hydrocodone/Acetaminophen Extended Release Placebo
Hide Arm/Group Description 1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses). 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) and 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses). 1 dose of 1 morphine extended release capsule and 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses). 1 dose of 1 hydrocodone/acetaminophen extended release tablet and 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses). 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) and 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
All-Cause Mortality
Acetaminophen Morphine Extended Release Morphine Extended Release/Acetaminophen Hydrocodone/Acetaminophen Extended Release Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Acetaminophen Morphine Extended Release Morphine Extended Release/Acetaminophen Hydrocodone/Acetaminophen Extended Release Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/52 (0.00%)   0/49 (0.00%)   0/48 (0.00%)   0/51 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Acetaminophen Morphine Extended Release Morphine Extended Release/Acetaminophen Hydrocodone/Acetaminophen Extended Release Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/50 (38.00%)   21/52 (40.38%)   26/49 (53.06%)   27/48 (56.25%)   20/51 (39.22%) 
Gastrointestinal disorders           
CONSTIPATION  1  0/50 (0.00%)  3/52 (5.77%)  1/49 (2.04%)  3/48 (6.25%)  3/51 (5.88%) 
DIARRHOEA  1  3/50 (6.00%)  0/52 (0.00%)  0/49 (0.00%)  1/48 (2.08%)  2/51 (3.92%) 
NAUSEA  1  6/50 (12.00%)  7/52 (13.46%)  11/49 (22.45%)  16/48 (33.33%)  9/51 (17.65%) 
VOMITING  1  1/50 (2.00%)  4/52 (7.69%)  6/49 (12.24%)  7/48 (14.58%)  3/51 (5.88%) 
Investigations           
ALANINE AMINOTRANSFERASE INCREASED  1  3/50 (6.00%)  1/52 (1.92%)  2/49 (4.08%)  0/48 (0.00%)  1/51 (1.96%) 
Metabolism and nutrition disorders           
DEHYDRATION  1  0/50 (0.00%)  1/52 (1.92%)  3/49 (6.12%)  0/48 (0.00%)  0/51 (0.00%) 
Nervous system disorders           
DIZZINESS  1  4/50 (8.00%)  4/52 (7.69%)  9/49 (18.37%)  6/48 (12.50%)  3/51 (5.88%) 
HEADACHE  1  6/50 (12.00%)  8/52 (15.38%)  9/49 (18.37%)  8/48 (16.67%)  5/51 (9.80%) 
SOMNOLENCE  1  3/50 (6.00%)  4/52 (7.69%)  3/49 (6.12%)  3/48 (6.25%)  2/51 (3.92%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01038609     History of Changes
Other Study ID Numbers: M12-058
First Submitted: December 22, 2009
First Posted: December 24, 2009
Results First Submitted: November 1, 2013
Results First Posted: March 7, 2014
Last Update Posted: April 8, 2014