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NCT00640835 · ClinicalTrials.gov registry record · Phase 2
Safety and Tolerability of Buprenorphine/Naloxone Film Strips
A Phase 2 study, sponsored by Indivior.
- Completed
- Registry status
- Phase 2
- Development phase
- 382
- Enrollment target
NCT00640835: Completed Phase 2 study, sponsored by Indivior.
NCT00640835 is a Phase 2 study that has completed, run by Indivior. The registered enrollment target is 382 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (187% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00640835, a Phase 2 study, has completed, sponsored by Indivior.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 382 participants
- Enrollment target
Study Summary
This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.
Primary Outcome
Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows: Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs
Interventions
- DRUG Buprenorphine/naloxone Film Strip
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2008-02 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
What the finished NCT00640835 record still lists
NCT00640835 is an interventional study that assigns participants to a tested intervention. The registered 382 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (187% higher).
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine/naloxone Film Strip is the first listed.
NCT00640835 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00640835 about?
NCT00640835 is a clinical study titled "Safety and Tolerability of Buprenorphine/Naloxone Film Strips". This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.
What is the current status of trial NCT00640835?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 382 participants. The study started on 2008-02. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00640835?
The interventions under investigation include: Buprenorphine/naloxone Film Strip (DRUG).
Who is sponsoring clinical trial NCT00640835?
This trial is sponsored by Indivior, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00640835's enrollment target sits among peer trials
382 111th of 2000 higher than 1,890 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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