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NCT00772785: PRO-809
An Open-label, Multi-center Extension Study of Probuphine in Patients With Opioid Dependence
Phase 3 trial testing Probuphine (buprenorphine implant) in Opioid Dependency in 16 participants. Terminated before completion.
1 February 2009
Quick facts
| Lead sponsor | Titan Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 1 September 2008 |
| Primary completion | 1 February 2009 |
| Estimated completion | 1 February 2009 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Probuphine (buprenorphine implant) — full drug profile →
Conditions studied
- Opioid Dependency — all drugs for Opioid Dependency →
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.
-
Number of adverse events
Time frame: 24 WEEKS
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.
Verify or expand the search:
- PubMed search for NCT00772785
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Titan Pharmaceuticals trials
Trials by the same sponsor.
- NCT03250117 — Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole · Phase 1, PHASE2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00772785 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Titan Pharmaceuticals
- Last refreshed: 27 December 2018
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing