An Open-Label 12 Month Study to Evaluate the Safety, Tolerability and Efficacy of OraVescent Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Noncancer Pain

NCT00228605 Phase 3 COMPLETED

The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl for the potential treatment of breakthrough pain episodes in patients who have chronic noncancer pain.

Details

Lead sponsor	Cephalon
Phase	Phase 3
Status	COMPLETED
Enrolment	500
Start date	2005-03
Completion	2007-05

Conditions

• Low Back Pain
• Migraine
• Diabetic Neuropathies
• Osteoarthritis

Interventions

• OraVescent Fentanyl

Primary outcomes

• Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients

Countries

United States