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| Sponsor: | Purdue Pharma LP |
|---|---|
| Information provided by: | Purdue Pharma LP |
| ClinicalTrials.gov Identifier: | NCT00490919 |
Purpose
The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Back Pain |
Drug: buprenorphine transdermal delivery systems Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Multi-Center, Randomized, Double-Blind, Placebo-Controlled With Open Label Run-in Study Assessing Efficacy, Tolerability, Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects With Moderate to Severe, Chronic Low Back Pain |
| Estimated Enrollment: | 520 |
| Study Start Date: | June 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Buprenorphine transdermal delivery system 10 and 20 worn for 7 days
|
Drug: buprenorphine transdermal delivery systems
transdermal delivery system 10 and 20 worn for 7 days
|
| 2: Placebo Comparator |
Drug: Placebo
transdermal delivery system (placebo) worn for 7 days
|
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific inclusion/exclusion criteria may apply.
Contacts and Locations
Show 86 Study Locations
More Information
| Responsible Party: | Purdue Pharma L.P. ( Medical Monitor ) |
| Study ID Numbers: | BUP3024 |
| Study First Received: | June 21, 2007 |
| Last Updated: | November 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00490919 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic pain opioid transdermal Moderate to severe chronic low back pain |
|
Narcotic Antagonists Nervous System Diseases Physiological Effects of Drugs Central Nervous System Depressants Low Back Pain Narcotics Pain Back Pain Pharmacologic Actions |
Signs and Symptoms Buprenorphine Sensory System Agents Therapeutic Uses Neurologic Manifestations Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |