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NCT00315887 · ClinicalTrials.gov registry record · Phase 3
The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.
A Phase 3 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
NCT00315887: Completed Phase 3 study, sponsored by Purdue Pharma.
NCT00315887 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 250 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00315887, a Phase 3 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
Study Summary
The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) will be provided to all subjects in addition to study drug.
Interventions
- DRUG Buprenorphine transdermal delivery system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 1999-04 |
| Est. Completion | 1999-10 |
| Phase | Phase 3 |
What the finished NCT00315887 record still lists
NCT00315887 is an interventional study that assigns participants to a tested intervention. The registered 250 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 (68% lower).
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine transdermal delivery system is the first listed.
NCT00315887 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00315887 about?
NCT00315887 is a clinical study titled "The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.". The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during...
What is the current status of trial NCT00315887?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 1999-04. Estimated completion is 1999-10.
What interventions are being tested in trial NCT00315887?
The interventions under investigation include: Buprenorphine transdermal delivery system (DRUG).
Who is sponsoring clinical trial NCT00315887?
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 NCT00315887's enrollment target sits among peer trials
250 1249th of 2000 higher than 735 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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