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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00723749 |
The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of substitution treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under everyday conditions.
Condition | Intervention |
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Opiate-Related Disorders Opiate Dependence Drug Abuse Buprenorphine Naloxone |
Drug: Buprenorphine/Naloxone |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Post-Marketing Surveillance Study (Paper-AWB) for GPs and Clinics: Treatment of Opioid-Dependent Patients With SUBOXONE® 2 mg / 8 mg Sublingual Tablets - Acceptability and Safety Dates From a Real Life Scenario. |
Estimated Enrollment: | 300 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Group 1
Patients where a substitution therapy with SUBOXONE® is planned or indicated, and who have already been pre-treated with SUBUTEX®, or another substitution medication for at least 6 months.
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Drug: Buprenorphine/Naloxone
Sublingual combination tablet containing buprenorphine and naloxone at a ration of 4:1, respectively. It is available in two tablet strengths: 2 mg buprenorphine / 0.5 mg naloxone and 8 mg buprenorphine / 2 mg naloxone. The only effective and safe use is sublingual administration. SUBOXONE® use will occur on the basis of SPC and is solely aimed at medical-therapeutic necessity.
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Nonprobability sampling was done by invitation to volunteer with the intention to document 4 to 5 patients per physician where a substitution therapy with Suboxone is planned or indicated.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Opioid-dependent patients where a substitution therapy with SUBOXONE® is planned or indicated, and who have already been pre-treated with SUBUTEX®, or another substitution medication for at least 6 months.
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05603 |
Study First Received: | July 25, 2008 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00723749 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Germany: National Association of Statutory Health Insurance Physicians; Germany: Federal Association of Company Health Insurance Fund |
Suboxone Subutex |
Buprenorphine Mental Disorders Narcotic Antagonists Substance-Related Disorders Central Nervous System Depressants Disorders of Environmental Origin |
Narcotics Peripheral Nervous System Agents Analgesics Opioid-Related Disorders Analgesics, Opioid Naloxone |
Narcotic Antagonists Physiological Effects of Drugs Central Nervous System Depressants Disorders of Environmental Origin Narcotics Opioid-Related Disorders Pharmacologic Actions Naloxone Buprenorphine |
Mental Disorders Sensory System Agents Therapeutic Uses Substance-Related Disorders Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |