OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
NCT ID: NCT00105937
Last Updated: 2012-06-29
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
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2004-04-30
2006-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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OraVescent fentanyl citrate
Eligibility Criteria
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Inclusion Criteria
* Average of 1-4 breakthrough pain episodes per day
* Opioid tolerant
* Histologically documented diagnosis of a malignant solid tumor or hematological malignancy
Exclusion Criteria
* Opioid or fentanyl intolerance
* Chronic obstructive pulmonary disease (COPD) or heart disease
* Sleep apnea or active brain metastases with increased cranial pressure
18 Years
80 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Locations
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Center for Pain Management
Huntsville, Alabama, United States
Outcomes Research International
Tucson, Arizona, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
Hot Spring Pain Clinic
Hot Springs, Arkansas, United States
Saint Joseph's Mercy Cancer Center
Hot Springs, Arkansas, United States
Arkansas Cancer Institute
Pine Bluff, Arkansas, United States
City of Hope National Medical Center
Duarte, California, United States
The Cancer Prevention and Treatment Center
Soquel, California, United States
Northwestern Connecticut Oncology & Hematology Associates
Torrington, Connecticut, United States
Florida Institute of Medical Research
Jacksonville, Florida, United States
University of Florida Shands Cancer Center at Jacksonville
Jacksonville, Florida, United States
Hematology Oncology Associates
Lake Worth, Florida, United States
Innovative Medical Research of South Florida
Miami Shores, Florida, United States
Gulf Coast Oncology Association
St. Petersburg, Florida, United States
Clinical Pharmacology Services, Inc
Tampa, Florida, United States
Palm Beach Research
West Palm Beach, Florida, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, United States
Southeastern Gynecologic Oncology, LLC
Atlanta, Georgia, United States
North Shore Cancer Research Association
Skokie, Illinois, United States
Kentucky Cancer Clinic
Hazard, Kentucky, United States
Southwest Oncology Associates
Lafayette, Louisiana, United States
Hematology and Oncology Specialists
New Orleans, Louisiana, United States
St. Agnes Healthcare
Baltimore, Maryland, United States
Huron Medical Center
Port Huron, Michigan, United States
Providence Cancer Institute
Southfield, Michigan, United States
Bond Clinic, Inc
Rolla, Missouri, United States
HealthCare Research, LLC
St Louis, Missouri, United States
North Shore University Hospital
Manhasset, New York, United States
Beth Israel Medical Center
New York, New York, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, United States
PETC Research Group, Inc.
Tulsa, Oklahoma, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
Allegheny Pain Management, PC
Altoona, Pennsylvania, United States
St. Mary Medical Center
Langhorne, Pennsylvania, United States
Mohamed Haq
Pasadena, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States
UTHCT (ATTN: Clinical Research)
Tyler, Texas, United States
Hunstman Cancer Institute
Salt Lake City, Utah, United States
Palliative Care and Pain Medicine
Salt Lake City, Utah, United States
Great Basin Clinical Research
West Point, Utah, United States
Cancer Outreach Associates, PC
Abingdon, Virginia, United States
MedSource Inc
Richmond, Virginia, United States
University of Wisconsin Medical School
Madison, Wisconsin, United States
Countries
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Other Identifiers
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099-15
Identifier Type: -
Identifier Source: org_study_id