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Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain

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ClinicalTrials.gov Identifier: NCT00312221
Recruitment Status : Terminated (terminated early for administrative reasons unrelated to safety or efficacy)
First Posted : April 7, 2006
Results First Posted : September 15, 2010
Last Update Posted : September 10, 2012
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Drug: Buprenorphine
Drug: oxycodone immediate-release
Enrollment 418
Recruitment Details Study Dates: 02-Apr-2004 (first subject first visit) to 18 Jul-2005 (last subject last visit); 15-Jun-2005 (first site notified of study termination). The study took place in 82 medical/research sites in the US; 59 sites randomized at least 1 subject.
Pre-assignment Details Men and women aged 40 years or older with OA of the hip, knee, or spine, on 30 to 80 mg/day morphine sulfate (MSO4) or equivalent, with or without nonopioid analgesic medication. (652 subjects entered the run-in period; 418 completed.) Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
Arm/Group Title Run-in Period Double-blind BTDS 5 Double-blind BTDS 20 Double-blind Oxycodone Immediate-Release
Hide Arm/Group Description The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period. Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Period Title: Open-label Run-in Period
Started 652 0 0 0
Completed 418 0 0 0
Not Completed 234 0 0 0
Reason Not Completed
Withdrawal by Subject             6             0             0             0
Adverse Event             74             0             0             0
Lost to Follow-up             5             0             0             0
Administrative             42             0             0             0
Lack of Efficacy             102             0             0             0
Did not qualify             5             0             0             0
Period Title: Double-blind Phase
Started 0 136 149 133
Completed 0 77 77 63
Not Completed 0 59 72 70
Reason Not Completed
Withdrawal by Subject             0             6             8             7
Adverse Event             0             10             19             18
Lost to Follow-up             0             0             2             2
Administrative             0             26             37             33
Lack of Efficacy             0             17             6             10
Arm/Group Title Double-blind BTDS 5 Double-blind BTDS 20 Double-blind Oxycodone Immediate-Release Total
Hide Arm/Group Description Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours). Total of all reporting groups
Overall Number of Baseline Participants 136 149 133 418
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 136 participants 149 participants 133 participants 418 participants
58.7  (10.71) 57.9  (9.45) 58.1  (10.36) 58.3  (10.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 136 participants 149 participants 133 participants 418 participants
Female
101
  74.3%
116
  77.9%
94
  70.7%
311
  74.4%
Male
35
  25.7%
33
  22.1%
39
  29.3%
107
  25.6%
1.Primary Outcome
Title “Average Pain Over the Last 24 Hours” Scores at Weeks 4, 8, and 12 of the Double-blind Phase.
Hide Description The “average pain over the last 24 hours” score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12).
Time Frame Weeks 4, 8, and 12 of the double-blind phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.
Arm/Group Title Double-blind BTDS 5 Double-blind BTDS 20 Double-blind Oxycodone Immediate-Release
Hide Arm/Group Description:
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Overall Number of Participants Analyzed 136 149 133
Mean (Standard Error)
Unit of Measure: Units on a scale
Screening 6.60  (0.116) 6.58  (0.103) 6.44  (0.117)
Prerandomization 3.25  (0.114) 3.02  (0.093) 3.03  (0.099)
Week 4 4.21  (0.219) 3.57  (0.195) 3.45  (0.209)
Week 8 3.78  (0.239) 3.37  (0.190) 3.59  (0.217)
Week 12 3.67  (0.246) 3.56  (0.230) 3.37  (0.232)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-blind BTDS 5, Double-blind BTDS 20
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.126
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-0.8562 to 0.1054
Estimation Comments Treatment comparison between BTDS 20 and BTDS 5 during the 12-week double-blind phase
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-blind BTDS 5, Double-blind Oxycodone Immediate-Release
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.36
Confidence Interval 95%
-0.8455 to 0.1189
Estimation Comments Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.
2.Secondary Outcome
Title The Mean Daily Number of Supplemental Analgesic Medication Tablets
Hide Description The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®.
Time Frame Double-blind phase (84 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.
Arm/Group Title Double-blind BTDS 5 Double-blind BTDS 20 Double-blind Oxycodone Immediate-Release
Hide Arm/Group Description:
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Overall Number of Participants Analyzed 136 149 133
Mean (Standard Error)
Unit of Measure: Tablets
Prerandomization 2.0  (0.19) 1.7  (0.13) 1.6  (0.13)
Double-blind 3.3  (0.26) 2.3  (0.19) 2.3  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-blind BTDS 5, Double-blind BTDS 20
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.47 to -0.20
Estimation Comments Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-blind BTDS 5, Double-blind Oxycodone Immediate-Release
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.47 to -0.17
Estimation Comments Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.
3.Secondary Outcome
Title The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase
Hide Description

The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete.

The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst).

Time Frame Weeks 4, 8 and 12 of the double-blind phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.
Arm/Group Title Double-blind BTDS 5 Double-blind BTDS 20 Double-blind Oxycodone Immediate-Release
Hide Arm/Group Description:
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Overall Number of Participants Analyzed 136 149 133
Mean (Standard Error)
Unit of Measure: Units on a scale
Screening 36.88  (1.093) 37.69  (0.930) 36.81  (1.043)
Prerandomization 25.96  (0.993) 24.19  (0.947) 24.42  (0.930)
Week 4 30.60  (1.187) 28.34  (1.025) 26.65  (1.253)
Week 8 28.70  (1.364) 28.34  (1.199) 26.59  (1.405)
Week 12 29.68  (1.500) 29.35  (1.253) 27.25  (1.651)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-blind BTDS 5, Double-blind BTDS 20
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.707
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-3.0054 to 2.0397
Estimation Comments Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-blind BTDS 5, Double-blind Oxycodone Immediate-Release
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.187
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.79
Confidence Interval (2-Sided) 95%
-4.4459 to 0.8706
Estimation Comments Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.
4.Secondary Outcome
Title The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
Hide Description The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity of optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.
Time Frame Weeks 4, 8, and 12 of the Double-blind Phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Population (N = 418) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug.
Arm/Group Title Double-blind BTDS 5 Double-blind BTDS 20 Double-blind Oxycodone Immediate-Release
Hide Arm/Group Description:
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Overall Number of Participants Analyzed 136 149 133
Mean (Standard Error)
Unit of Measure: Units on a scale
Screening 51.91  (2.139) 55.28  (2.035) 55.74  (2.197)
Prerandomization 34.64  (1.950) 28.65  (1.782) 33.03  (1.926)
Week 4 39.23  (2.144) 32.40  (1.941) 35.72  (2.298)
Week 8 35.95  (2.791) 31.71  (2.473) 34.13  (2.746)
Week 12 39.13  (3.089) 32.95  (2.819) 36.32  (3.290)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Double-blind BTDS 5, Double-blind BTDS 20
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.685
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-5.6177 to 3.6930
Estimation Comments Treatment comparison between BTDS 5 and BTDS 20 during the 12-week double-blind phase.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Double-blind BTDS 5, Double-blind Oxycodone Immediate-Release
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.443
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.81
Confidence Interval (2-Sided) 95%
-6.4415 to 2.8255
Estimation Comments Treatment comparison between BTDS 5 and oxycodone immediate-release during the 12-week double-blind phase.
Time Frame Adverse Events (AEs) occurring after the signing of informed consent up to study completion or discontinuation; during 7 days after last visit; serious AEs up to 30 days following the last study visit were followed until the event resolved.
Adverse Event Reporting Description AEs were obtained through spontaneous reports and subject interview.
 
Arm/Group Title Double-blind BTDS 5 Double-blind BTDS 20 Double-blind Oxycodone Immediate-Release Run-in, Open-label BTDS 10 and 20
Hide Arm/Group Description Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear during the 12-week double-blind phase Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear during the 12-week double-blind phase Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours) during the 12-week double-blind phase. The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period.
All-Cause Mortality
Double-blind BTDS 5 Double-blind BTDS 20 Double-blind Oxycodone Immediate-Release Run-in, Open-label BTDS 10 and 20
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Double-blind BTDS 5 Double-blind BTDS 20 Double-blind Oxycodone Immediate-Release Run-in, Open-label BTDS 10 and 20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/136 (2.21%)      7/149 (4.70%)      7/133 (5.26%)      8/652 (1.23%)    
Cardiac disorders         
Acute coronary syndrome  1 [1]  0/136 (0.00%)  0 1/149 (0.67%)  1 0/133 (0.00%)  0 0/652 (0.00%)  0
Bradycardia  1 [1]  0/136 (0.00%)  0 1/149 (0.67%)  1 0/133 (0.00%)  0 0/652 (0.00%)  0
Chest pain with ischemic episode  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 0/133 (0.00%)  0 1/652 (0.15%)  1
Palpitations  1 [2]  0/136 (0.00%)  0 1/149 (0.67%)  1 0/133 (0.00%)  0 0/652 (0.00%)  0
Paroxysmal supraventricular tachycardia  1 [2]  0/136 (0.00%)  0 1/149 (0.67%)  1 0/133 (0.00%)  0 0/652 (0.00%)  0
Congenital, familial and genetic disorders         
Dermoid ovarian cyst  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 0/133 (0.00%)  0 1/652 (0.15%)  1
Gastrointestinal disorders         
Acute abdomen  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 1/133 (0.75%)  1 0/652 (0.00%)  0
Diarrhea  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 1/133 (0.75%)  1 0/652 (0.00%)  0
Exacerbation of Crohn's disease  1 [1]  0/136 (0.00%)  0 1/149 (0.67%)  1 0/133 (0.00%)  0 0/652 (0.00%)  0
GI bleeding  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 1/133 (0.75%)  1 0/652 (0.00%)  0
Nausea  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 0/133 (0.00%)  0 1/652 (0.15%)  1
Vomiting  1 [2]  0/136 (0.00%)  0 0/149 (0.00%)  0 0/133 (0.00%)  0 1/652 (0.15%)  1
Acid reflux  2 [2]  1/136 (0.74%)  1 0/149 (0.00%)  0 0/133 (0.00%)  0 0/652 (0.00%)  0
General disorders         
Chest pain  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 0/133 (0.00%)  0 1/652 (0.15%)  1
Fall  1 [3]  0/136 (0.00%)  0 1/149 (0.67%)  1 0/133 (0.00%)  0 0/652 (0.00%)  0
Fell  1 [3]  0/136 (0.00%)  0 0/149 (0.00%)  0 1/133 (0.75%)  1 0/652 (0.00%)  0
Hepatobiliary disorders         
Acute cholecystitis  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 1/133 (0.75%)  1 0/652 (0.00%)  0
Cholelithiasis  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 0/133 (0.00%)  0 1/652 (0.15%)  1
Injury, poisoning and procedural complications         
Fractured left hip  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 1/133 (0.75%)  1 0/652 (0.00%)  0
Postsurgical hip joint dislocation, left hip  1 [2]  0/136 (0.00%)  0 0/149 (0.00%)  0 0/133 (0.00%)  0 1/652 (0.15%)  1
Metabolism and nutrition disorders         
Dehydration  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 1/133 (0.75%)  1 0/652 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Muscle spasms right knee  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 0/133 (0.00%)  0 1/652 (0.15%)  1
Recurrent L4-L5 disc herniation  1 [2]  0/136 (0.00%)  0 0/149 (0.00%)  0 1/133 (0.75%)  1 0/652 (0.00%)  0
End stage OA of the right knee  2 [4]  0/136 (0.00%)  0 1/149 (0.67%)  1 0/133 (0.00%)  0 0/652 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Liver cancer  1 [1]  1/136 (0.74%)  1 0/149 (0.00%)  0 0/133 (0.00%)  0 0/652 (0.00%)  0
Possible bone cancer  1 [2]  1/136 (0.74%)  1 0/149 (0.00%)  0 0/133 (0.00%)  0 0/652 (0.00%)  0
Prostatic adenocarcinoma  1 [2]  0/136 (0.00%)  0 0/149 (0.00%)  0 0/133 (0.00%)  0 1/652 (0.15%)  1
Nervous system disorders         
Exacerbation of lumbar spinal stenosis  1 [1]  0/136 (0.00%)  0 1/149 (0.67%)  1 0/133 (0.00%)  0 0/652 (0.00%)  0
Recurrent L5-S1 disc herniation with impingement of the S1 nerve root  1 [2]  0/136 (0.00%)  0 0/149 (0.00%)  0 1/133 (0.75%)  1 0/652 (0.00%)  0
Transischemic attack  1 [2]  0/136 (0.00%)  0 0/149 (0.00%)  0 1/133 (0.75%)  1 0/652 (0.00%)  0
Renal and urinary disorders         
Acute renal failure  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 1/133 (0.75%)  1 0/652 (0.00%)  0
Renal calculi  1 [2]  0/136 (0.00%)  0 1/149 (0.67%)  1 0/133 (0.00%)  0 0/652 (0.00%)  0
Reproductive system and breast disorders         
Enlarged uterus  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 0/133 (0.00%)  0 1/652 (0.15%)  1
Metrorrhagia  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 0/133 (0.00%)  0 1/652 (0.15%)  1
Respiratory, thoracic and mediastinal disorders         
Bronchospasm  1 [1]  1/136 (0.74%)  1 0/149 (0.00%)  0 0/133 (0.00%)  0 0/652 (0.00%)  0
Pulmonary embolism  1 [2]  0/136 (0.00%)  0 0/149 (0.00%)  0 0/133 (0.00%)  0 1/652 (0.15%)  1
Worsening asthma  1 [2]  1/136 (0.74%)  1 0/149 (0.00%)  0 0/133 (0.00%)  0 0/652 (0.00%)  0
Social circumstances         
OxyIR abuse  1 [1]  0/136 (0.00%)  0 1/149 (0.67%)  1 0/133 (0.00%)  0 0/652 (0.00%)  0
Vascular disorders         
Deep vein thrombosis  1 [1]  0/136 (0.00%)  0 0/149 (0.00%)  0 0/133 (0.00%)  0 1/652 (0.15%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (5.1)
2
Term from vocabulary, MedDRA (10.0)
[1]
Systematic and nonsystematic assessment
[2]
Systematic and nonsystematic assessments.
[3]
Systematic and nonsystematic assessment "Fall" and "Fell" are listed as 2 separate categories.
[4]
Systematic and nonsystematic assessments
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4.50%
Double-blind BTDS 5 Double-blind BTDS 20 Double-blind Oxycodone Immediate-Release Run-in, Open-label BTDS 10 and 20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/136 (22.06%)      70/149 (46.98%)      56/133 (42.11%)      187/652 (28.68%)    
Gastrointestinal disorders         
Nausea  1 [1]  4/136 (2.94%)  16/149 (10.74%)  17/133 (12.78%)  94/652 (14.42%) 
Constipation  1 [1]  3/136 (2.21%)  8/149 (5.37%)  9/133 (6.77%)  22/652 (3.37%) 
Vomiting NOS  1 [1]  0/136 (0.00%)  8/149 (5.37%)  6/133 (4.51%)  32/652 (4.91%) 
Abdominal pain upper  1 [1]  1/136 (0.74%)  0/149 (0.00%)  6/133 (4.51%)  1/652 (0.15%) 
General disorders         
Application site pruritus  1 [1]  13/136 (9.56%)  22/149 (14.77%)  12/133 (9.02%)  47/652 (7.21%) 
Application site rash  1 [1]  5/136 (3.68%)  9/149 (6.04%)  8/133 (6.02%)  9/652 (1.38%) 
Application site erythema  1 [1]  9/136 (6.62%)  14/149 (9.40%)  5/133 (3.76%)  9/652 (1.38%) 
Pain NOS  1 [2]  5/136 (3.68%)  1/149 (0.67%)  7/133 (5.26%)  11/652 (1.69%) 
Infections and infestations         
Upper respiratory tract infection NOS  1 [2]  6/136 (4.41%)  6/149 (4.03%)  8/133 (6.02%)  5/652 (0.77%) 
Urinary tract infection NOS  1 [2]  5/136 (3.68%)  8/149 (5.37%)  5/133 (3.76%)  9/652 (1.38%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1 [2]  5/136 (3.68%)  9/149 (6.04%)  4/133 (3.01%)  12/652 (1.84%) 
Pain in limb  1 [2]  7/136 (5.15%)  2/149 (1.34%)  3/133 (2.26%)  14/652 (2.15%) 
Nervous system disorders         
Headache  1 [2]  10/136 (7.35%)  22/149 (14.77%)  16/133 (12.03%)  70/652 (10.74%) 
Dizziness  1 [2]  4/136 (2.94%)  10/149 (6.71%)  7/133 (5.26%)  43/652 (6.60%) 
Somnolence  1 [2]  2/136 (1.47%)  2/149 (1.34%)  10/133 (7.52%)  29/652 (4.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (5.1)
[1]
Systematic and nonsystematic assessments
[2]
Systematic and nonsystematic assessments.
This study was terminated early for administrative reasons not related to safety or efficacy. Low enrollment at termination led to reduced power.
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.
Results Point of Contact
Name/Title: Clinical Leader, Medical Director
Organization: Purdue Pharma L.P.
Phone: 800-733-1333
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00312221     History of Changes
Other Study ID Numbers: BUP3019
First Submitted: April 6, 2006
First Posted: April 7, 2006
Results First Submitted: July 15, 2010
Results First Posted: September 15, 2010
Last Update Posted: September 10, 2012