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)
Southern Oregon Health & Wellness
🇺🇸Medford, Oregon, United States
Capital Clinical Research Associates, LLC
🇺🇸Rockville, Maryland, United States
Rowan Research
🇺🇸Spokane, Washington, United States
Brigham Women's Hospital, Attn: Pain Trials Center
🇺🇸Boston, Massachusetts, United States
Clinical Research Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Mid-America Physiatrists, PA
🇺🇸Overland Park, Kansas, United States
MedSearch
🇺🇸Calera, Alabama, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
NEA Clinic
🇺🇸Jonesboro, Arkansas, United States
Clinical Research Consultants, Inc.
🇺🇸Hoover, Alabama, United States
Radiant Research-Daytona Beach
🇺🇸Daytona Beach, Florida, United States
Advent Clinical Research Centers, Inc.
🇺🇸Atlanta, Georgia, United States
North Fulton Regional Hospital Pain Center
🇺🇸Roswell, Georgia, United States
Gold Coast Research
🇺🇸Weston, Florida, United States
Carmen Research
🇺🇸Smyrna, Georgia, United States
Center for Prospective Outcome Studies, Inc.
🇺🇸Marietta, Georgia, United States
Orthopedic Health Care
🇺🇸Boise, Idaho, United States
Tri-State Arthritis & Rheumatology Center, LLC
🇺🇸Evansville, Indiana, United States
Medisphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Iowa Pain Management Clinic, PC
🇺🇸Des Moines, Iowa, United States
MedVadis Research
🇺🇸Wellesley Hills, Massachusetts, United States
Radiant Research - St. Louis
🇺🇸St. Louis, Missouri, United States
Medex Healthcare Research Center
🇺🇸St. Louis, Missouri, United States
NYU Pain Management Center
🇺🇸New York, New York, United States
Northshore University Hospital
🇺🇸Beth Page, New York, United States
Research Across America
🇺🇸New York, New York, United States
The Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Research Center of Reading, LLP
🇺🇸West Reading, Pennsylvania, United States
Healthstar Physicians
🇺🇸Morristown, Tennessee, United States
Biopharma Research Associates
🇺🇸Sugar Land, Texas, United States
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Pain Management Center
🇺🇸South Burlington, Vermont, United States
Radiant Research
🇺🇸Salt Lake City, Utah, United States