Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain
Status:
Completed
Trial end date:
2019-02-01
Target enrollment:
Participant gender:
Summary
This is a Phase III, placebo-controlled, multicenter study with an enriched-enrollment
withdrawal (EEW) 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 ≥ 40 mg morphine equivalent dose (MED). The study includes 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 Treatment Phase including a Final Study Visit (12 weeks), and a
Follow-up Phase (4 weeks). The overall duration of participation in the core phase of the
study (randomized Double-Blind Phase) is up to 30 weeks, from the Screening Phase through the
Follow-up Phase. Subjects who complete the Double-Blind Treatment Study Phase will be offered
an opportunity to continue treatment in an open label safety extension for up to 60 weeks.
Additional subjects may be recruited to open label safety extension to meet the goal of 100
subjects with 60 weeks of treatment.