Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain
- Conditions
- Diabetic NeuropathiesOsteoarthritisLow Back PainMigraine
- Registration Number
- NCT00228605
- Lead Sponsor
- Cephalon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- Chronic pain diagnosis
- Opioid tolerant
- Has on average 1-4 breakthrough pain episodes per day
- Drug abuse history
- Cardiopulmonary disease
- Monoamine oxidase inhibitors (MAOIs)
- Expected to have surgery to relieve the pain
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients
- Secondary Outcome Measures
Name Time Method Assess the patients' quality of life through questionnaires Assess the patients' overall medication preferences Assess the patients' overall medication performance
Trial Locations
- Locations (36)
MedSearch
🇺🇸Calera, Alabama, United States
Clinical Research Consultants, Inc.
🇺🇸Hoover, Alabama, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
NEA Clinic
🇺🇸Jonesboro, Arkansas, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Radiant Research-Daytona Beach
🇺🇸Daytona Beach, Florida, United States
Advent Clinical Research Centers, Inc.
🇺🇸Atlanta, Georgia, United States
Gold Coast Research
🇺🇸Weston, Florida, United States
Center for Prospective Outcome Studies, Inc.
🇺🇸Marietta, Georgia, United States
North Fulton Regional Hospital Pain Center
🇺🇸Roswell, Georgia, United States
Scroll for more (26 remaining)MedSearch🇺🇸Calera, Alabama, United States