Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain

Cephalon

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis; Diabetic Neuropathies; Migraine; Low Back Pain

Treatments: Drug: OraVescent Fentanyl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00228605

C25608/3040/BP/US

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic pain diagnosis
• Opioid tolerant
• Has on average 1-4 breakthrough pain episodes per day

Exclusion criteria

• Drug abuse history
• Cardiopulmonary disease
• Monoamine oxidase inhibitors (MAOIs)
• Expected to have surgery to relieve the pain

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)