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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00605033 |
Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
Condition | Intervention | Phase |
---|---|---|
Opiate Dependence Drug Dependence |
Drug: Suboxone, Buprenorphone Hydrochloride + Naloxone, SCH 484 Drug: Subutex, Buprenorphine Hydrochloride, SCH 28444 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment |
Official Title: | A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects |
Estimated Enrollment: | 240 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Suboxone Active ( plus Subutex Placebo): Active Comparator
None
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Drug: Suboxone, Buprenorphone Hydrochloride + Naloxone, SCH 484
Suboxone sublingual tablet 4-24 mg, daily for 28 days
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Subutex Active (plus Suboxone Placebo): Active Comparator
None
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Drug: Subutex, Buprenorphine Hydrochloride, SCH 28444
Subutex sublingual tablet 4-24 mg, daily for 28 days
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Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
Croatia | |
Investigational Site 11 | Recruiting |
Zagreb, Croatia, 10000 | |
Investigational Site 12 | Recruiting |
Rijeka, Croatia, 51000 | |
Investigational Site 13 | Active, not recruiting |
Zagreb, Croatia, 10090 | |
Denmark | |
Investigational Site 33 | Recruiting |
Rodovre, Denmark, 2610 | |
France | |
Investigational Site 3 | Recruiting |
Lyon Cedex 3, France, 69437 | |
Investigational Site 2 | Recruiting |
Bagneux, France, 92220 | |
Investigational Site 4 | Recruiting |
Nice Cedex 1, France, 06006 | |
Investigational Site 5 | Recruiting |
Villejuif Cedex, France, 94804 | |
Investigational Site 38 | Recruiting |
Limoges Cedex, France, 87027 | |
Norway | |
Investigational Site 31 | Recruiting |
Arendal, Norway, 4809 | |
Slovenia | |
Investigational Site 26 | Recruiting |
Koper, Slovenia, 6000 | |
Investigational Site 27 | Recruiting |
Piran, Slovenia, 6320 | |
Sweden | |
Investigational Site 36 | Recruiting |
Goteborg, Sweden, 41685 | |
Investigational Site 37 | Completed |
Malmo, Sweden, 21122 | |
United Kingdom | |
Investigational Site 16 | Recruiting |
Plymouth, United Kingdom, PY4 6LF |
Study Director: | Leslie Amass, PhD | Schering-Plough |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04843, SWITCH |
Study First Received: | January 17, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00605033 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Buprenorphine Mental Disorders Substance-Related Disorders |
Disorders of Environmental Origin Opioid-Related Disorders Naloxone |
Sensory System Agents Therapeutic Uses Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |