OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
- Conditions
- PainCancer
- Registration Number
- NCT00105937
- Lead Sponsor
- Cephalon
- Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of OraVescent fentanyl to treat breakthrough pain episodes in cancer patients who are already opioid tolerant.
- Detailed Description
The objective of this study is to determine the tolerability and safety of OraVescent fentanyl when used long term to relieve breakthrough pain in opioid tolerant cancer patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 18-80 years of age
- Average of 1-4 breakthrough pain episodes per day
- Opioid tolerant
- Histologically documented diagnosis of a malignant solid tumor or hematological malignancy
- Primary breakthrough pain is not related to cancer in any way
- Opioid or fentanyl intolerance
- Chronic obstructive pulmonary disease (COPD) or heart disease
- Sleep apnea or active brain metastases with increased cranial pressure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Tolerability and safety of OraVescent fentanyl when used long-term
- Secondary Outcome Measures
Name Time Method Assess the effectiveness of OraVescent fentanyl Assess the development of incremental tolerance
Trial Locations
- Locations (43)
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States
Hunstman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Palliative Care and Pain Medicine
🇺🇸Salt Lake City, Utah, United States
Center for Pain Management
🇺🇸Huntsville, Alabama, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Outcomes Research International
🇺🇸Tucson, Arizona, United States
Hot Spring Pain Clinic
🇺🇸Hot Springs, Arkansas, United States
Arkansas Cancer Institute
🇺🇸Pine Bluff, Arkansas, United States
Saint Joseph's Mercy Cancer Center
🇺🇸Hot Springs, Arkansas, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Palm Beach Research
🇺🇸West Palm Beach, Florida, United States
Northwestern Connecticut Oncology & Hematology Associates
🇺🇸Torrington, Connecticut, United States
Gulf Coast Oncology Association
🇺🇸St. Petersburg, Florida, United States
Florida Institute of Medical Research
🇺🇸Jacksonville, Florida, United States
University of Florida Shands Cancer Center at Jacksonville
🇺🇸Jacksonville, Florida, United States
Florida Medical Clinic, PA
🇺🇸Zephyrhills, Florida, United States
Innovative Medical Research of South Florida
🇺🇸Miami Shores, Florida, United States
North Shore Cancer Research Association
🇺🇸Skokie, Illinois, United States
Southeastern Gynecologic Oncology, LLC
🇺🇸Atlanta, Georgia, United States
Providence Cancer Institute
🇺🇸Southfield, Michigan, United States
St. Agnes Healthcare
🇺🇸Baltimore, Maryland, United States
Hematology and Oncology Specialists
🇺🇸New Orleans, Louisiana, United States
Southwest Oncology Associates
🇺🇸Lafayette, Louisiana, United States
HealthCare Research, LLC
🇺🇸St. Louis, Missouri, United States
Huron Medical Center
🇺🇸Port Huron, Michigan, United States
The Center for Clinical Research, LLC
🇺🇸Winston-Salem, North Carolina, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
PETC Research Group, Inc.
🇺🇸Tulsa, Oklahoma, United States
St. Mary Medical Center
🇺🇸Langhorne, Pennsylvania, United States
Allegheny Pain Management, PC
🇺🇸Altoona, Pennsylvania, United States
Mohamed Haq
🇺🇸Pasadena, Texas, United States
UTHCT (ATTN: Clinical Research)
🇺🇸Tyler, Texas, United States
Great Basin Clinical Research
🇺🇸West Point, Utah, United States
MedSource Inc
🇺🇸Richmond, Virginia, United States
Cancer Outreach Associates, PC
🇺🇸Abingdon, Virginia, United States
University of Wisconsin Medical School
🇺🇸Madison, Wisconsin, United States
Bond Clinic, Inc
🇺🇸Rolla, Missouri, United States
Hematology Oncology Associates
🇺🇸Lake Worth, Florida, United States
Clinical Pharmacology Services, Inc
🇺🇸Tampa, Florida, United States
Kentucky Cancer Clinic
🇺🇸Hazard, Kentucky, United States
Oncology Associates of Oregon
🇺🇸Eugene, Oregon, United States
The Cancer Prevention and Treatment Center
🇺🇸Soquel, California, United States