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NCT00490919 · ClinicalTrials.gov registry record · Phase 3
Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain
A Phase 3 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 539
- Enrollment target
NCT00490919: Completed Phase 3 study, sponsored by Purdue Pharma.
NCT00490919 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 539 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00490919, a Phase 3 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 539 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 low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.
Primary Outcome
Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.
Interventions
- DRUG Placebo
- DRUG Buprenorphine transdermal system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 539 participants |
| Start Date | 2007-06 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00490919 record still lists
NCT00490919 is an interventional study that assigns participants to a tested intervention. The registered 539 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 (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00490919 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00490919 about?
NCT00490919 is a clinical study titled "Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain". 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 low back pain. The double-blind treatment intervention duration is 12 weeks, during which ti...
What is the current status of trial NCT00490919?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 539 participants. The study started on 2007-06. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00490919?
The interventions under investigation include: Placebo (DRUG), Buprenorphine transdermal system (DRUG).
Who is sponsoring clinical trial NCT00490919?
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 NCT00490919's enrollment target sits among peer trials
539 700th of 2000 higher than 1,301 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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