Last updated on November 2017

Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain


Brief description of study

Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain

Detailed Study Description

This study will be a Phase III, placebo-controlled, multicenter study with an enriched-enrollment withdrawal design to evaluate the efficacy and safety of CAM2038 in opioid-experienced subjects with moderate to severe CLBP that requires continuous, around-the-clock (ATC) opioid treatment. The study will comprise 5 phases: a Screening Phase (up to 2 weeks), a Transition Phase (up to 2 weeks), an open label Titration Phase (up to 10 weeks), a Double-Blind Phase including a Final Study Visit (12 weeks), and a Follow-up Phase (4 weeks). The overall duration of participation will be up to 32 weeks, from Screening Phase to Follow up Phase, including 12 weeks of double-blinded treatment.

Clinical Study Identifier: TX12293

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Coastal Carolina Research Center

Coastal Carolina Research Center
Mount Pleasant, SC USA
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