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NCT00315445 · ClinicalTrials.gov registry record · Phase 3
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
A Phase 3 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 134
- Enrollment target
NCT00315445: Completed Phase 3 study, sponsored by Purdue Pharma.
NCT00315445 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 134 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00315445, a Phase 3 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 134 participants
- Enrollment target
Study Summary
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.
Primary Outcome
Subjects were asked, "Please rate your pain by circling the one number (0-10) that best describes your pain on the average since your last visit." 0 = no pain and 10 = pain as bad as you can imagine it.
Interventions
- DRUG Buprenorphine transdermal patch
- DRUG Placebo oxycodone/acetaminophen tablets
- DRUG OXY/APAP
- DRUG Placebo transdermal patch (TDS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 1997-12 |
| Est. Completion | 1998-05 |
| Phase | Phase 3 |
What the finished NCT00315445 record still lists
NCT00315445 is an interventional study that assigns participants to a tested intervention. The registered 134 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 (83% lower).
The record links to 0 conditions, and to 4 interventions - of which Buprenorphine transdermal patch is the first listed.
NCT00315445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00315445 about?
NCT00315445 is a clinical study titled "The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.". The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days durin...
What is the current status of trial NCT00315445?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 134 participants. The study started on 1997-12. Estimated completion is 1998-05.
What interventions are being tested in trial NCT00315445?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG), Placebo oxycodone/acetaminophen tablets (DRUG), OXY/APAP (DRUG), Placebo transdermal patch (TDS) (DRUG).
Who is sponsoring clinical trial NCT00315445?
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 NCT00315445's enrollment target sits among peer trials
134 1585th of 2000 higher than 413 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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