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Sponsored by: |
Mundipharma K.K. |
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Information provided by: | Mundipharma K.K. |
ClinicalTrials.gov Identifier: | NCT00346047 |
The primary objective of this study is to evaluate the efficacy and safety of BTDS compared to placebo in subjects with moderate to severe low back pain.
Condition | Intervention | Phase |
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Low Back Pain |
Drug: Placebo Drug: Buprenorphine Transdermal System |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Determine the Efficacy and Safety of BTDS Compared to Placebo in Subjects With Moderate to Severe Low Back Pain |
Enrollment: | 238 |
Study Start Date: | May 2006 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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0: Placebo Comparator |
Drug: Placebo
Corresponding placebo is applied for 12weeks
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1: Experimental |
Drug: Buprenorphine Transdermal System
Buprenorphine Transdermal System 5, 10 or 20 mg/patch is applied for 12weeks
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The primary objective of this study is to evaluate the efficacy and safety of buprenorphine transdermal system (BTDS) compared to placebo in subjects with moderate to severe low back pain who have a sub-optimal response to their non-opioid analgesic treatment and require opioid analgesics for pain control.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Mutsukuni Kataoka | Department Head, Clinical Trial Operations, Clinical Development, Mundipharma K.K. |
Responsible Party: | Mundipharma K.K. ( Mutsukuni Kataoka ) |
Study ID Numbers: | BUP3802 |
Study First Received: | June 27, 2006 |
Last Updated: | April 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00346047 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Signs and Symptoms Buprenorphine Neurologic Manifestations |
Low Back Pain Pain Back Pain |
Sensory System Agents Therapeutic Uses Narcotic Antagonists Physiological Effects of Drugs Nervous System Diseases Central Nervous System Depressants |
Narcotics Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |