Endo Low Back Pain 308
A Phase 3, Double-Blind, Placebo-Controlled, Multicenter, Randomized Withdrawal Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of BEMA Buprenorphine in Opioid-Naiive Subjects with Noderate to Severe Chronic Low Back Pain Requiring Around-the-Clock Opioid Analgesia for an Extended Period of Time.
| Protocol | EN3409-308 |
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| Identifier | EN3409-308 Site Number 1034 |
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| UID | 23e952ed-465c-4118-9bb6-a695c4e750f7 |
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| Status | Done - Archived |
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| Phase | 3 |
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| Category | Low Back Pain |
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| Launch Year | 2012 |
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| NCT Number | - |
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| Created | 2012-05-30 12:08 |
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| Last Updated | 2012-05-30 12:08 |
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Description
Key Elements:
• Study purpose: To determine the analgesic efficacy of BEMA Buprenorphine Q12h in opioid-naïve subjects with moderate to severe CLBP
• Study drug: Buprenorphine is a semi-synthetic opioid that is used to control moderate chronic pain that has already been approved by the FDA for use as a sublingual tablet and transdermal patch.
• Study Drug Administration: Medication is administered via a BioErodible MucoAdhesive strip that is applied to the buccal mucosa (inside lining of the cheeks) every 12 hours. The strip dissolves in approximately 15 to 30 minutes.
• Up to 20 visits (24 weeks/6 months)
• Stipend: $40
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