Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain
NCT ID: NCT00228605
Last Updated: 2014-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2005-03-31
2007-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain
NCT00214955
Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain
NCT00343733
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain
NCT00214942
Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
NCT00105287
OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
NCT00105937
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
OraVescent Fentanyl
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Opioid tolerant
* Has on average 1-4 breakthrough pain episodes per day
Exclusion Criteria
* Cardiopulmonary disease
* Monoamine oxidase inhibitors (MAOIs)
* Expected to have surgery to relieve the pain
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cephalon
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gwendolyn Neibler, DO
Role: STUDY_DIRECTOR
Cephalon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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.
St. Petersburg, Florida, United States
Gold Coast Research
Weston, Florida, United States
Center for Prospective Outcome Studies, Inc.
Atlanta, Georgia, United States
Advent Clinical Research Centers, Inc.
Atlanta, Georgia, United States
Center for Prospective Outcome Studies, Inc.
Marietta, Georgia, United States
North Fulton Regional Hospital Pain Center
Roswell, Georgia, United States
Carmen Research
Smyrna, Georgia, United States
Orthopedic Health Care
Boise, Idaho, United States
Medisphere Medical Research Center, LLC
Evansville, Indiana, United States
Tri-State Arthritis & Rheumatology Center, LLC
Evansville, Indiana, United States
Iowa Pain Management Clinic, PC
Des Moines, Iowa, United States
Mid-America Physiatrists, PA
Overland Park, Kansas, United States
Capital Clinical Research Associates, LLC
Rockville, Maryland, United States
Brigham Women's Hospital, Attn: Pain Trials Center
Boston, Massachusetts, United States
MedVadis Research
Wellesley Hills, Massachusetts, United States
Medex Healthcare Research Center
St Louis, Missouri, United States
Radiant Research - St. Louis
St Louis, Missouri, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Northshore University Hospital
Bethpage, New York, United States
NYU Pain Management Center
New York, New York, United States
Research Across America
New York, New York, United States
The Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Southern Oregon Health & Wellness
Medford, Oregon, 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
Radiant Research
Salt Lake City, Utah, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Pain Management Center
South Burlington, Vermont, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Rowan Research
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C25608/3040/BP/US
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.