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

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

Outcome

Met primary endpoint

registry analysis (unspecified test); Buprenorphine Hydrochloride; p <0.0001; Mean Difference (Final Values) 1.77 (95% CI 1.35 to 2.19) NCT01075971 ↗

Drugs

Indications