MedTrace Logo

A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED)

NCT00605033 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2016-10-21

Study results available
· View outcomes & findings →

Summary

Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.

Conditions

  • Opiate Dependence
  • Drug Dependence

Interventions

DRUG

Suboxone, Buprenorphine Hydrochloride + Naloxone, SCH 484

Suboxone sublingual tablet 4 mg/1 mg - 24 mg/6 mg, daily for 28 days

DRUG

Subutex, Buprenorphine Hydrochloride, SCH 28444

Subutex sublingual tablet 4-24 mg, daily for 28 days

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-04-30
Completion
2009-05-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00605033 on ClinicalTrials.gov