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NCT00315835 · ClinicalTrials.gov registry record · Phase 2
Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.
A Phase 2 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT00315835 is a Phase 2 study that has completed, run by Purdue Pharma. The registered enrollment target is 100 participants.
The verdict
NCT00315835, a Phase 2 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72 hours during which time supplemental analgesic medication (intravenous morphine PCA) will be provided to all subjects in addition to study drug.
Interventions
- DRUG Buprenorphine transdermal delivery system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 1996-10 |
| Est. Completion | 1997-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00315835
The ClinicalTrials.gov registry entry for NCT00315835 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 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 1 intervention - of which Buprenorphine transdermal delivery system is the first listed.
NCT00315835 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00315835 about?
NCT00315835 is a clinical study titled "Safety of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Pain Following Orthopedic Surgery.". The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. The double-blind treatment intervention duration is 72 hours during which time...
What is the current status of trial NCT00315835?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 1996-10. Estimated completion is 1997-11.
What interventions are being tested in trial NCT00315835?
The interventions under investigation include: Buprenorphine transdermal delivery system (DRUG).
Who is sponsoring clinical trial NCT00315835?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
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