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NCT00772785: PRO-809

An Open-label, Multi-center Extension Study of Probuphine in Patients With Opioid Dependence

Terminated Phase 3 Last updated 27 December 2018
What this trial tests

Phase 3 trial testing Probuphine (buprenorphine implant) in Opioid Dependency in 16 participants. Terminated before completion.

Timeline
1 September 2008
Primary endpoint
1 February 2009
1 February 2009

Quick facts

Lead sponsorTitan Pharmaceuticals
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment16
Start date1 September 2008
Primary completion1 February 2009
Estimated completion1 February 2009
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Titan Pharmaceuticals — full company profile →

Who can join

Adults 18 to 65, any sex, with Opioid Dependency. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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 patients with opioid dependence. Patients who have completed at least 24 weeks of treatment in the Open-Label, Multi-Center Study of Probuphine in Patients with Opioid Dependence (PRO-807 Study), will be re-treated with Probuphine over an additional 24 weeks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Titan Pharmaceuticals trials

Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00772785.

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