Conditions: Low Back Pain Osteoarthritis Neuropathic Pain
Keywords: Chronic Pain CLBP Chronic Low Back Pain Back Pain Osteoarthritis OA Neuropathic Pain Nerve pain Painful neuropathy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 304
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Buprenorphine HCI Buccal File at doses ranging from 300-900 mcg twice daily

Interventions: intervention 1: EN3409
Intervention descriptions: intervention 1: Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily

Protocol document: