Who is sponsoring NCT01262261?

NCT01262261 is sponsored by Titan Pharmaceuticals.

What drugs are being tested in NCT01262261?

Interventions in NCT01262261: Probuphine (buprenorphine implant).

What condition does NCT01262261 study?

NCT01262261 studies Opioid Dependency.

Is NCT01262261 still recruiting?

NCT01262261 is currently completed. Last updated 27 December 2018.

Last reviewed 2018-12-27 · How we verify

NCT01262261

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 3, Six-Month, Open-Label, Re-Treatment Study of Probuphine in Opioid Addiction

Completed Phase 3 Last updated 27 December 2018

What this trial tests

Phase 3 trial testing Probuphine (buprenorphine implant) in Opioid Dependency in 85 participants. Completed in 1 November 2011.

Timeline

1 November 2010

Primary endpoint
1 November 2011

1 November 2011

Quick facts

Lead sponsor	Titan Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	85
Start date	1 November 2010
Primary completion	1 November 2011
Estimated completion	1 November 2011
Sites	18 locations 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 subjects with Adverse Events (AEs) as a measure of safety
Time frame: 29 weeks
AEs that occurred after the signing of the informed consent until 4 weeks after the implants have been removed were followed. Serious AEs and AEs that were designated as possibly related to study drug were followed until resolution or stabilization.

Sponsor's own description

Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01262261 (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/NCT01262261.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing