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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 is a Phase 2 study that has completed, run by Indivior. The registered enrollment target is 382 participants.

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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.

Interventions

  • DRUG Buprenorphine/naloxone Film Strip

Trial Details

FieldValue
Enrollment Target 382 participants
Start Date 2008-02
Est. Completion 2008-10
Phase Phase 2

Sponsor

Indivior

37 total trials

What the Registry Record Tells You About NCT00640835

The ClinicalTrials.gov registry entry for NCT00640835 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 382 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indivior, which has 37 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Buprenorphine/naloxone Film Strip is the first listed.

NCT00640835 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.