Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
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|ClinicalTrials.gov Identifier: NCT00313846|
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : September 28, 2010
Last Update Posted : September 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Drug: Buprenorphine transdermal patch Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||529 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||June 2004|
|Actual Study Completion Date :||June 2004|
Buprenorphine transdermal patch 5, 10 or 20 micrograms/hour (mcg/h)
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
Other Name: Butrans™
Placebo Comparator: Placebo
Placebo to match BTDS 5, 10 or 20 mcg/h
Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
- The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site. [ Time Frame: Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods ]
- "average pain over the last 24 hours" score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or;
- >1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or;
- ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia.
- Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site [ Time Frame: 7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. ]The daily maximum 'pain right now' score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. "Pain right now" scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine).
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): NCT00313846