NCT01755546

Long-term Open-Label Safety Study to Evaluate EN3409

A Phase 3, Open-label, Long-term Study to Evaluate the Safety, Tolerability, and Analgesic Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain Requiring Continuous Around-the-Clock Opioid Analgesia for an Extended Period of Time

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: BioDelivery Sciences International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.

Conditions

• Low Back Pain
• Osteoarthritis
• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	EN3409	Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-10-01
• Completion: 2014-11-01
• First posted: 2012-12-24
• Last updated: 2018-10-18
• Results posted: 2018-09-12

Locations

57 sites across 1 country: United States