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A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01571362
First received: April 3, 2012
Last updated: February 17, 2017
Last verified: February 2017
Results First Received: October 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Chronic Pain
Low Back Pain
Analgesia
Interventions: Drug: ALO-02
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Determine the Efficacy and Safety of ALO-02 Extended-Release Capsules in participants with Moderate to Severe Chronic Low Back Pain

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 410 participants were enrolled into the Open-Label Conversion and Titration Period and 281 participants were randomized into the Double-Blind Treatment Period, of which, 280 participants received study treatment.

Reporting Groups
  Description
Open ALO-02 Participants received AL0-02 extended-release capsules, orally (PO), twice daily (BID), at total daily doses of oxycodone from 20 to 160 milligrams (mg) in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
ALO-02 To Placebo Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
ALO-02 To ALO-02 Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.

Participant Flow for 2 periods

Period 1:   Open-Label Conversion + Titration Period
    Open ALO-02   ALO-02 To Placebo   ALO-02 To ALO-02
STARTED   410   0 [1]   0 [1] 
COMPLETED   281   0 [1]   0 [1] 
NOT COMPLETED   129   0   0 
Withdrawal by Subject                11                0                0 
Protocol Violation                7                0                0 
Adverse Event                57                0                0 
Lost to Follow-up                10                0                0 
Does not meet entrance criteria                41                0                0 
Other - unspecified                3                0                0 
[1] This phase commenced after the Open-Label Period.

Period 2:   Double-Blind Treatment Period
    Open ALO-02   ALO-02 To Placebo   ALO-02 To ALO-02
STARTED   0 [1]   134   146 
COMPLETED   0 [1]   81   107 
NOT COMPLETED   0   53   39 
Withdrawal by Subject                0                11                5 
Protocol Violation                0                8                9 
Adverse Event                0                9                14 
Lost to Follow-up                0                3                6 
Insufficient clinical response                0                16                4 
Other - unspecified                0                6                1 
[1] This phase preceded the Double-Blind Treatment Period.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Open ALO-02 Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.

Baseline Measures
   Open ALO-02 
Overall Participants Analyzed 
[Units: Participants]
 410 
Age, Customized [1] 
[Units: Participants]
 
Between 18 and 65 years   364 
>=65 years   46 
[1] Age measure using NLM-defined categories.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Female      233  56.8% 
Male      177  43.2% 
[1] Gender


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12)   [ Time Frame: Weeks 11 and 12 ]

2.  Secondary:   Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit).   [ Time Frame: Week 12 ]

3.  Secondary:   Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit).   [ Time Frame: Randomization Baseline, Week 12 ]

4.  Secondary:   Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20%   [ Time Frame: Weeks 11 and 12 ]

5.  Secondary:   Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30%   [ Time Frame: Weeks 11 and 12 ]

6.  Secondary:   Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40%   [ Time Frame: Weeks 11 and 12 ]

7.  Secondary:   Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50%   [ Time Frame: Weeks 11 and 12 ]

8.  Secondary:   Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index   [ Time Frame: Screening, Week 4, 5, or 6 ]

9.  Secondary:   Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index   [ Time Frame: Screening, Randomization Baseline ]

10.  Secondary:   Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain   [ Time Frame: Weeks 2, 4, 8, and 12 ]

11.  Secondary:   Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain   [ Time Frame: Weeks 2, 4, 8, and 12 ]

12.  Secondary:   Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain   [ Time Frame: Weeks 2, 4, 8, and 12 ]

13.  Secondary:   Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now   [ Time Frame: Weeks 2, 4, 8, and 12 ]

14.  Secondary:   Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index   [ Time Frame: Weeks 2, 4, 8, and 12 ]

15.  Secondary:   Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index   [ Time Frame: Weeks 2, 4, 8, and 12 ]

16.  Secondary:   Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain   [ Time Frame: Weeks 2, 4, 8 and 12 ]

17.  Secondary:   Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain   [ Time Frame: Weeks 2, 4, 8, and 12 ]

18.  Secondary:   Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain   [ Time Frame: Weeks 2, 4, 8, and 12 ]

19.  Secondary:   Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now   [ Time Frame: Weeks 2, 4, 8, and 12 ]

20.  Secondary:   Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index   [ Time Frame: Weeks 2, 4, 8, and 12 ]

21.  Secondary:   Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index   [ Time Frame: Weeks 2, 4, 8, and 12 ]

22.  Secondary:   Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12)   [ Time Frame: Randomization Baseline, Weeks 11 and 12 ]

23.  Secondary:   Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period   [ Time Frame: Daily from Day 1 of the Double-Blind Period through Week 12 ]

24.  Secondary:   Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment   [ Time Frame: Screening, Week 4, 5 or 6 ]

25.  Secondary:   Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment   [ Time Frame: Screening, Week 4, 5, or 6 ]

26.  Secondary:   Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline   [ Time Frame: Screening, Randomization Baseline (up to 6 weeks) ]

27.  Secondary:   Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline   [ Time Frame: Screening, Randomization Baseline (up to 6 weeks) ]

28.  Secondary:   Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period   [ Time Frame: Randomization Baseline, up to Week 12 ]

29.  Secondary:   Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period   [ Time Frame: Randomization Baseline, up to Week 12 ]

30.  Secondary:   Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy   [ Time Frame: Week 1 up to Week 12 ]

31.  Secondary:   Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period   [ Time Frame: Week 1 up to Week 12 ]

32.  Secondary:   Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period   [ Time Frame: Screening, Weeks 1, 2, 3, 4, 5, and 6 ]

33.  Secondary:   COWS Total Score During the Double-Blind Treatment Period   [ Time Frame: Randomization Baseline, Weeks 1, 2, 4, 8, and 12 ]

34.  Secondary:   COWS Total Score During the Post-Treatment Period   [ Time Frame: Follow-Up (FU) Weeks 1 and 2 ]

35.  Secondary:   Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category   [ Time Frame: Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination) ]

36.  Secondary:   Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category   [ Time Frame: Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination) ]

37.  Secondary:   Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category   [ Time Frame: Follow-Up Weeks 1 and 2 ]

38.  Secondary:   Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period   [ Time Frame: Screening, Weeks 1, 2, 3, 4, 5, and 6 ]

39.  Secondary:   SOWS Total Score During the Double-Blind Treatment Period   [ Time Frame: Randomization Baseline, Weeks 1, 2, 4, 8, and 12 ]

40.  Secondary:   SOWS Total Score During the Post-Treatment Period   [ Time Frame: Follow-Up Weeks 1 and 2 ]

41.  Secondary:   Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants   [ Time Frame: Screening, Week 6 (or Early Termination) ]

42.  Secondary:   Change From Screening Period to Randomization Baseline in RMDQ Total Score   [ Time Frame: Screening, Randomization Baseline ]

43.  Secondary:   Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score   [ Time Frame: Screening, Weeks 2, 4, 8, and 12 ]

44.  Secondary:   Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score   [ Time Frame: Randomization Baseline, Weeks 2, 4, and 8 ]

45.  Secondary:   Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor   [ Time Frame: Screening, Randomization Baseline ]

46.  Secondary:   Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor   [ Time Frame: Screening, Randomization Baseline, or Early Termination ]

47.  Secondary:   Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor   [ Time Frame: Randomization Baseline, Week 4 ]

48.  Secondary:   Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor   [ Time Frame: Randomization Baseline, Week 8 ]

49.  Secondary:   Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants   [ Time Frame: End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination) ]

50.  Secondary:   Satisfaction With Treatment at Randomization Baseline   [ Time Frame: Randomization Baseline ]

51.  Secondary:   Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period   [ Time Frame: Week 12 or Early Termination ]

52.  Secondary:   Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score   [ Time Frame: Screening, Week 6 (or Early Termination) ]

53.  Secondary:   Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score   [ Time Frame: Screening, Randomization Baseline ]

54.  Secondary:   Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey   [ Time Frame: Randomization Baseline, Week 12 ]

55.  Secondary:   Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey   [ Time Frame: Screening, Week 12 ]

56.  Secondary:   Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index   [ Time Frame: Screening, Week 6 (or Early Termination) ]

57.  Secondary:   Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS   [ Time Frame: Screening, Week 6 (or Early Termination) ]

58.  Secondary:   Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index   [ Time Frame: Screening, Randomization Baseline ]

59.  Secondary:   Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS   [ Time Frame: Screening, Randomization Baseline ]

60.  Secondary:   Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index   [ Time Frame: Randomization Baseline, Week 12 ]

61.  Secondary:   Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS   [ Time Frame: Randomization Baseline, Week 12 ]

62.  Secondary:   Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index   [ Time Frame: Screening, Week 12 ]

63.  Secondary:   Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS   [ Time Frame: Screening, Week 12 ]

64.  Secondary:   Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain   [ Time Frame: Screening, Week 6 (or Early Termination) ]

65.  Secondary:   Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain   [ Time Frame: Screening, Randomization Baseline ]

66.  Secondary:   Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain   [ Time Frame: Randomization Baseline, Weeks 4, 8, and 12 ]

67.  Secondary:   Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain   [ Time Frame: Randomization Baseline, Weeks 4, 8, and 12 ]

68.  Secondary:   Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain   [ Time Frame: Randomization Baseline, Weeks 4, 8, and 12 ]

69.  Secondary:   Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain   [ Time Frame: Randomization Baseline, Weeks 4, 8, and 12 ]

70.  Secondary:   Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain   [ Time Frame: Screening, Weeks 4, 8, and 12 ]

71.  Secondary:   Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain   [ Time Frame: Screening, Weeks 4, 8, and 12 ]

72.  Secondary:   Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain   [ Time Frame: Screening, Weeks 4, 8, and 12 ]

73.  Secondary:   Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain   [ Time Frame: Screening, Weeks 4, 8, and 12 ]

74.  Secondary:   Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire   [ Time Frame: Screening, Week 6 (or Early Termination) ]

75.  Secondary:   Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire   [ Time Frame: Screening, Randomization Baseline ]

76.  Secondary:   Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain   [ Time Frame: Screening, Randomization Baseline ]

77.  Secondary:   Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks   [ Time Frame: Screening, Randomization Baseline ]

78.  Secondary:   Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital   [ Time Frame: Screening, Randomization Baseline ]

79.  Secondary:   Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain   [ Time Frame: Screening, Week 6 (or Early Termination) ]

80.  Secondary:   Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks   [ Time Frame: Screening, Week 6 (or Early Termination) ]

81.  Secondary:   Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital   [ Time Frame: Screening, Week 6 (or Early Termination) ]

82.  Secondary:   Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire   [ Time Frame: Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination) ]

83.  Secondary:   Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain   [ Time Frame: Randomization Baseline, Weeks 4, 8, and 12 ]

84.  Secondary:   Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments   [ Time Frame: Randomization Baseline, Weeks 4, 8, and 12 ]

85.  Secondary:   Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital   [ Time Frame: Randomization Baseline, Weeks 4, 8, and 12 ]

86.  Secondary:   Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire   [ Time Frame: Screening, Weeks 4, 8, and 12 ]

87.  Secondary:   Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain   [ Time Frame: Screening, Weeks 4, 8, and 12 ]

88.  Secondary:   Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain   [ Time Frame: Screening, Weeks 4, 8, and 12 ]

89.  Secondary:   Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain   [ Time Frame: Screening, Weeks 4, 8, and 12 ]

90.  Secondary:   Mean Oxycodone Average Daily Dose During the Open-Label Titration Period   [ Time Frame: Open-Label Period ]

91.  Secondary:   Mean Oxycodone Duration of Titration During the Open-Label Titration Period   [ Time Frame: Open-Label Period ]

92.  Secondary:   Median Oxycodone Average Daily Dose During the Open-Label Titration Period   [ Time Frame: Open-Label Period ]

93.  Secondary:   Median Oxycodone Duration of Titration During the Open-Label Titration Period   [ Time Frame: Open-Label Period ]

94.  Secondary:   Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period   [ Time Frame: Double-Blind Period ]

95.  Secondary:   Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period   [ Time Frame: Double-Blind Period ]

96.  Secondary:   Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period   [ Time Frame: Double-Blind Period ]

97.  Secondary:   Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period   [ Time Frame: Double-Blind Period ]

98.  Secondary:   Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period   [ Time Frame: Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline ]

99.  Secondary:   Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period   [ Time Frame: Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline ]

100.  Secondary:   Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period   [ Time Frame: Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12 ]

101.  Secondary:   Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period   [ Time Frame: Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01571362     History of Changes
Other Study ID Numbers: B4531002
ALO-02-10-3002 ( Other Identifier: Alias Study Number )
Study First Received: April 3, 2012
Results First Received: October 6, 2016
Last Updated: February 17, 2017