OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients
1 other identifier
interventional
300
1 country
43
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 pain
Started Apr 2004
Typical duration for phase_3 pain
43 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
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 18, 2005
CompletedFirst Posted
Study publicly available on registry
March 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedJune 29, 2012
May 1, 2007
March 18, 2005
June 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tolerability and safety of OraVescent fentanyl when used long-term
Secondary Outcomes (2)
Assess the effectiveness of OraVescent fentanyl
Assess the development of incremental tolerance
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (43)
Center for Pain Management
Huntsville, Alabama, 35801, United States
Outcomes Research International
Tucson, Arizona, 85711, United States
Arizona Clinical Research Center
Tucson, Arizona, 85712, United States
Hot Spring Pain Clinic
Hot Springs, Arkansas, 71913, United States
Saint Joseph's Mercy Cancer Center
Hot Springs, Arkansas, 71913, United States
Arkansas Cancer Institute
Pine Bluff, Arkansas, 71603, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
The Cancer Prevention and Treatment Center
Soquel, California, 95073, United States
Northwestern Connecticut Oncology & Hematology Associates
Torrington, Connecticut, 06790, United States
Florida Institute of Medical Research
Jacksonville, Florida, 32207, United States
University of Florida Shands Cancer Center at Jacksonville
Jacksonville, Florida, 32209, United States
Hematology Oncology Associates
Lake Worth, Florida, 33461-4710, United States
Innovative Medical Research of South Florida
Miami Shores, Florida, 33138, United States
Gulf Coast Oncology Association
St. Petersburg, Florida, 33705, United States
Clinical Pharmacology Services, Inc
Tampa, Florida, 33617, United States
Palm Beach Research
West Palm Beach, Florida, 33409, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542, United States
Southeastern Gynecologic Oncology, LLC
Atlanta, Georgia, 30342, United States
North Shore Cancer Research Association
Skokie, Illinois, 60076, United States
Kentucky Cancer Clinic
Hazard, Kentucky, 41701, United States
Southwest Oncology Associates
Lafayette, Louisiana, 70503, United States
Hematology and Oncology Specialists
New Orleans, Louisiana, 70115, United States
St. Agnes Healthcare
Baltimore, Maryland, 21229, United States
Huron Medical Center
Port Huron, Michigan, 48067, United States
Providence Cancer Institute
Southfield, Michigan, 48075, United States
Bond Clinic, Inc
Rolla, Missouri, 65407, United States
HealthCare Research, LLC
St Louis, Missouri, 63141, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Beth Israel Medical Center
New York, New York, 10003, United States
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103, United States
PETC Research Group, Inc.
Tulsa, Oklahoma, 74137, United States
Oncology Associates of Oregon
Eugene, Oregon, 97401, United States
Allegheny Pain Management, PC
Altoona, Pennsylvania, 16601, United States
St. Mary Medical Center
Langhorne, Pennsylvania, 19047, United States
Mohamed Haq
Pasadena, Texas, 77504, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78229, United States
UTHCT (ATTN: Clinical Research)
Tyler, Texas, 75708, United States
Hunstman Cancer Institute
Salt Lake City, Utah, 84112, United States
Palliative Care and Pain Medicine
Salt Lake City, Utah, 84157, United States
Great Basin Clinical Research
West Point, Utah, 84015, United States
Cancer Outreach Associates, PC
Abingdon, Virginia, 24211, United States
MedSource Inc
Richmond, Virginia, 23229, United States
University of Wisconsin Medical School
Madison, Wisconsin, 53792-5669, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
March 18, 2005
First Posted
March 21, 2005
Study Start
April 1, 2004
Study Completion
November 1, 2006
Last Updated
June 29, 2012
Record last verified: 2007-05