drugset / Trial / NCT01075971

Study of Two Formulations of Buprenorphine HCl in Opioid-dependent Subjects on Buprenorphine Maintenance Therapy (Study P04451) (COMPLETED)

NCT01075971

Phase 2 Completed 52 enrolled Indivior Inc. Reckitt Benckiser Inc. · collab
NaSingle-groupOpen-labelTreatment

Summary

This is a multi-center, open-label, preference study of two sublingual formulations of buprenorphine HCl, in opioid-dependent patients on buprenorphine maintenance therapy. The objectives of this study are to evaluate the overall preference between two buprenorphine sublingual formulations, after a switch from the marketed tablet (Subutex®) to the new fast dissolving tablet (FDT), in opioid-dependent patients with buprenorphine 8 mg or 16 mg daily maintenance therapy.

Timeline

Start
2005-09
Primary completion
2005-11
Completion
2005-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 8 mg Other
Subject Buprenorphine Other / unclassified 16 mg Other

Indications