Status:
COMPLETED
Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain
Lead Sponsor:
Cephalon
Conditions:
Low Back Pain
Migraine
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- Chronic pain diagnosis
- Opioid tolerant
- Has on average 1-4 breakthrough pain episodes per day
Exclusion
- Drug abuse history
- Cardiopulmonary disease
- Monoamine oxidase inhibitors (MAOIs)
- Expected to have surgery to relieve the pain
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00228605
Start Date
March 1 2005
End Date
May 1 2007
Last Update
May 9 2014
Active Locations (38)
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1
MedSearch
Calera, Alabama, United States, 35040
2
Clinical Research Consultants, Inc.
Hoover, Alabama, United States, 35216
3
Arizona Research Center
Phoenix, Arizona, United States, 85023
4
NEA Clinic
Jonesboro, Arkansas, United States, 72404