OraVescent Fentanyl (OVF) for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Completed · Phase 3

Conditions studied: Pain, Cancer

In brief

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.

Key facts

Study ID

NCT00105937

Run by

Cephalon

People needed

300

Starts

2004-04-01

Expected to finish

2006-11-01

Last updated by the study team

2012-06-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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