drugset / Trial / NCT01755546

Long-term Open-Label Safety Study to Evaluate EN3409

NCT01755546

Phase 3 Completed 304 enrolled BioDelivery Sciences International
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2012-12
Primary completion
2014-10
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 300 ug Other
Subject Buprenorphine Other / unclassified 900 ug Other