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NCT00312195 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
A Phase 3 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 267
- Enrollment target
NCT00312195: Completed Phase 3 study, sponsored by Purdue Pharma.
NCT00312195 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 267 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00312195, a Phase 3 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 267 participants
- Enrollment target
Study Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.
Primary Outcome
Ineffective treatment was defined as: * Subject took \>1 gram of acetaminophen in a 24-hour period, or * Subject required a change in transdermal patch (TDS) dose, or * Subject had difficulty in keeping the TDS on, or * Subject discontinued due to ineffective treatment (but did not meet any of the above criteria). Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective tre
Interventions
- DRUG Buprenorphine transdermal patch
- DRUG Placebo to match BTDS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 267 participants |
| Start Date | 2001-03 |
| Est. Completion | 2001-07 |
| Phase | Phase 3 |
What the finished NCT00312195 record still lists
NCT00312195 is an interventional study that assigns participants to a tested intervention. The registered 267 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 (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Buprenorphine transdermal patch is the first listed.
NCT00312195 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00312195 about?
NCT00312195 is a clinical study titled "Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain". The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind tre...
What is the current status of trial NCT00312195?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 267 participants. The study started on 2001-03. Estimated completion is 2001-07.
What interventions are being tested in trial NCT00312195?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG), Placebo to match BTDS (DRUG).
Who is sponsoring clinical trial NCT00312195?
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 NCT00312195's enrollment target sits among peer trials
267 1222nd of 2000 higher than 779 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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