Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioDelivery Sciences International; Endo Pharmaceuticals
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

• Male or non-pregnant and non-nursing female aged 18 or older

• History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 [11 point numerical rating scale] reported at the open-label titration period Day 0/1 visit following a washout period (opioids, nonsteroidal anti-inflammatory drugs [NSAIDs], and muscle relaxants) of approximately 12 to 24 hours

• Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer

• Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and screening laboratory results so as to comply with all study procedures

• Female subjects of childbearing potential must be using a recognized effective method of birth control

• Written informed consent obtained at Screening, prior to any procedure being performed

Exclusion Criteria:

• Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis

• Surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening

• Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia

• Corrected QT (QTc) interval of >450 milliseconds on the 12-lead electrocardiogram (ECG)

• History of long QT syndrome, or an immediate family member with this condition

• Diagnosis of moderate to severe hepatic impairment.

• History of severe emesis with opioids

• Clinically significant sleep apnea