Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain
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
1 other identifier
interventional
500
1 country
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 low-back-pain
Started Mar 2005
Typical duration for phase_3 low-back-pain
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 27, 2005
CompletedFirst Posted
Study publicly available on registry
September 29, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedMay 9, 2014
May 1, 2014
September 27, 2005
May 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients
Secondary Outcomes (3)
Assess the patients' quality of life through questionnaires
Assess the patients' overall medication preferences
Assess the patients' overall medication performance
Interventions
Eligibility Criteria
You may qualify if:
- Chronic pain diagnosis
- Opioid tolerant
- Has on average 1-4 breakthrough pain episodes per day
You may not qualify if:
- Drug abuse history
- Cardiopulmonary disease
- Monoamine oxidase inhibitors (MAOIs)
- Expected to have surgery to relieve the pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (38)
MedSearch
Calera, Alabama, 35040, United States
Clinical Research Consultants, Inc.
Hoover, Alabama, 35216, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
NEA Clinic
Jonesboro, Arkansas, 72404, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80909, United States
Radiant Research-Daytona Beach
Daytona Beach, Florida, 32114, United States
Advent Clinical Research Centers, Inc.
St. Petersburg, Florida, 33703, United States
Gold Coast Research
Weston, Florida, 33331, United States
Center for Prospective Outcome Studies, Inc.
Atlanta, Georgia, 30327, United States
Advent Clinical Research Centers, Inc.
Atlanta, Georgia, 30342, United States
Center for Prospective Outcome Studies, Inc.
Marietta, Georgia, 30060, United States
North Fulton Regional Hospital Pain Center
Roswell, Georgia, 30076, United States
Carmen Research
Smyrna, Georgia, 30080, United States
Orthopedic Health Care
Boise, Idaho, 83702, United States
Medisphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Tri-State Arthritis & Rheumatology Center, LLC
Evansville, Indiana, 47714, United States
Iowa Pain Management Clinic, PC
Des Moines, Iowa, 50265, United States
Mid-America Physiatrists, PA
Overland Park, Kansas, 66211, United States
Capital Clinical Research Associates, LLC
Rockville, Maryland, 20852, United States
Brigham Women's Hospital, Attn: Pain Trials Center
Boston, Massachusetts, 02115, United States
MedVadis Research
Wellesley Hills, Massachusetts, 02481-2106, United States
Medex Healthcare Research Center
St Louis, Missouri, 63108, United States
Radiant Research - St. Louis
St Louis, Missouri, 63141, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104, United States
Northshore University Hospital
Bethpage, New York, 11714, United States
NYU Pain Management Center
New York, New York, 10016, United States
Research Across America
New York, New York, 10022, United States
The Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Southern Oregon Health & Wellness
Medford, Oregon, 97504, United States
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, 19611, United States
Healthstar Physicians
Morristown, Tennessee, 37813, United States
Biopharma Research Associates
Sugar Land, Texas, 77479, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
Radiant Research
Salt Lake City, Utah, 84107, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Pain Management Center
South Burlington, Vermont, 05403, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
Rowan Research
Spokane, Washington, 99207, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gwendolyn Neibler, DO
Cephalon
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 27, 2005
First Posted
September 29, 2005
Study Start
March 1, 2005
Study Completion
May 1, 2007
Last Updated
May 9, 2014
Record last verified: 2014-05