A 52-Week, Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain

NCT01298765 Phase 3 COMPLETED Results posted

The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.

Details

Lead sponsor	BioDelivery Sciences International
Phase	Phase 3
Status	COMPLETED
Enrolment	302
Start date	2011-03
Completion	2012-08

Conditions

• Pain
• Low Back Pain
• Osteoarthritis
• Neuropathic Pain

Interventions

• BEMA Buprenorphine

Primary outcomes

• Change From Baseline in NRS Pain Intensity — Baseline up to approximately Week 52
  The NRS Pain intensity score is a segmented version of a visual analog scale used to measure pain. The scale is from 0 (no pain) to 10. Scores between greater than 0 and 3 are considered mild pain, scores from greater than 3 to 6 are moderate and greater than 6 to 10 are severe. The daily average is calculated and used to calculate the change from baseline at week 52.

Countries

United States