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NCT00313846 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee
A Phase 3 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 529
- Enrollment target
NCT00313846: Completed Phase 3 study, sponsored by Purdue Pharma.
NCT00313846 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 529 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00313846, a Phase 3 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 529 participants
- Enrollment target
Study Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
Primary Outcome
Inadequate analgesia: * "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 = long
Interventions
- DRUG Placebo
- DRUG Buprenorphine transdermal patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 529 participants |
| Start Date | 2003-04 |
| Est. Completion | 2004-06 |
| Phase | Phase 3 |
What the finished NCT00313846 record still lists
NCT00313846 is an interventional study that assigns participants to a tested intervention. The registered 529 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00313846 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00313846 about?
NCT00313846 is a clinical study titled "Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee". The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. ...
What is the current status of trial NCT00313846?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 529 participants. The study started on 2003-04. Estimated completion is 2004-06.
What interventions are being tested in trial NCT00313846?
The interventions under investigation include: Placebo (DRUG), Buprenorphine transdermal patch (DRUG).
Who is sponsoring clinical trial NCT00313846?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00313846's enrollment target sits among peer trials
529 709th of 2000 higher than 1,290 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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