Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01141283 |
Recruitment Status
:
Completed
First Posted
: June 10, 2010
Results First Posted
: September 21, 2010
Last Update Posted
: September 3, 2012
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis | Drug: Buprenorphine transdermal patch | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 290 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to Sev OA Pain of Hip or Knee: A 6-Month Open-label Extension Phase |
Study Start Date : | April 2003 |
Actual Primary Completion Date : | July 2004 |
Actual Study Completion Date : | July 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: BTDS
Buprenorphine transdermal patch
|
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
- The Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months. ]Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.
Exclusion Criteria:
- Excluded from the study are subjects who ingest > 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.
- Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug] or transdermal fentanyl during the extension phase should be discontinued from the study.
Refer to core study for additional inclusion/exclusion information.

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): NCT01141283

Additional Information:
Responsible Party: | Purdue Pharma LP |
ClinicalTrials.gov Identifier: | NCT01141283 History of Changes |
Other Study ID Numbers: |
BUP3012S |
First Posted: | June 10, 2010 Key Record Dates |
Results First Posted: | September 21, 2010 |
Last Update Posted: | September 3, 2012 |
Last Verified: | August 2012 |
Keywords provided by Purdue Pharma LP:
Osteoarthritis Opioid Transdermal |
Additional relevant MeSH terms:
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Buprenorphine Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |