Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee
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|ClinicalTrials.gov Identifier: NCT00531427|
Recruitment Status : Completed
First Posted : September 18, 2007
Results First Posted : September 21, 2010
Last Update Posted : September 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Osteoarthritis of the Knee||Drug: Buprenorphine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||567 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||November 2009|
Buprenorphine transdermal system 10 and 20 applied for 7-day wear
transdermal system 10 and 20 applied for 7-day wear
Placebo Comparator: 2
Placebo transdermal system to match BTDS patches, applied for 7-day wear
transdermal system (placebo) applied for 7-day wear
- "Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase. [ Time Frame: 24 hours (week 12) ]"Average pain over the last 24 hours" scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily.
- Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase. [ Time Frame: 10 weeks ]Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen).
- Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase. [ Time Frame: Weeks 4, 8, and 12 of the double-bind phase ]The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and 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 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531427
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