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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 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 539 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00490919
The ClinicalTrials.gov registry entry for NCT00490919 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 539 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00490919 reports 0 study locations.
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.
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