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NCT00531427 · ClinicalTrials.gov registry record · Phase 3
Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee
A Phase 3 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 567
- Enrollment target
NCT00531427 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 567 participants.
The verdict
NCT00531427, a Phase 3 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 567 participants
- Enrollment target
Study Summary
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.
Interventions
- DRUG Placebo
- DRUG Buprenorphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 567 participants |
| Start Date | 2007-09 |
| Est. Completion | 2009-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00531427
The ClinicalTrials.gov registry entry for NCT00531427 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 567 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00531427 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00531427 about?
NCT00531427 is a clinical study titled "Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee". The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duratio...
What is the current status of trial NCT00531427?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 567 participants. The study started on 2007-09. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00531427?
The interventions under investigation include: Placebo (DRUG), Buprenorphine (DRUG).
Who is sponsoring clinical trial NCT00531427?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
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