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NCT00630201 · ClinicalTrials.gov registry record · Phase 3
Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence
A Phase 3 study, sponsored by Titan Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
NCT00630201: Completed Phase 3 study, sponsored by Titan Pharmaceuticals.
NCT00630201 is a Phase 3 study that has completed, run by Titan Pharmaceuticals. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00630201, a Phase 3 study, has completed, sponsored by Titan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
Study Summary
Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin that contains BPN. It is designed to provide 6 months of stable BPN blood levels. This study will test the safety and efficacy of Probuphine in the treatment of patient with opioid dependence. Patients who have completed 24 weeks of treatment in the Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Probuphine in Patients with Opioid Dependence, will be re-treated with Probuphine over an additional 24 weeks.
Primary Outcome
Adverse events that occurred after the signing of the informed consent until 14 days after study drug treatment has been discontinued, or AEs designated as possibly-related to study drug and all Serious AEs until resolution or stabilization, were followed.
Interventions
- DRUG Probuphine (buprenorphine implant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-02 |
| Phase | Phase 3 |
What the finished NCT00630201 record still lists
NCT00630201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Probuphine (buprenorphine implant) is the first listed.
NCT00630201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00630201 about?
NCT00630201 is a clinical study titled "Extension to Safety and Efficacy of Probuphine in the Treatment of Opioid Dependence". Buprenorphine (BPN) is an approved treatment for opioid dependence; however, in taking oral tablets, patients experience withdrawal and cravings when the variable BPN levels in the blood are low. Probuphine (buprenorphine implant) is an implant placed just beneath the skin that contains BPN. It is d...
What is the current status of trial NCT00630201?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2007-10. Estimated completion is 2009-02.
What interventions are being tested in trial NCT00630201?
The interventions under investigation include: Probuphine (buprenorphine implant) (DRUG).
Who is sponsoring clinical trial NCT00630201?
This trial is sponsored by Titan Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00630201's enrollment target sits among peer trials
62 1802nd of 2000 higher than 198 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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