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 safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.

Key facts

Study ID

NCT00105287

Run by

Cephalon

People needed

100

Starts

2005-01-01

Expected to finish

2007-09-01

Last updated by the study team

2014-05-09

Who can join

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

You may qualify if…

• Documented diagnosis of a malignant solid tumor or hematological malignancy causing cancer related pain
• Currently taking around the clock opioid therapy for pain
• Experience on average, 1-4 breakthrough pain episodes per day

You may not qualify if…

• Opioid or fentanyl intolerance
• Sleep apnea or active brain metastases with increased intracranial pressure
• COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease

Where it is running

• Cullman Oncology and Hematology — Cullman, Alabama, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Pacific Cancer Medical Center — Anaheim, California, United States
• Compassionate Cancer Care Medical Group — Corona, California, United States
• Compassionate Cancer Center — Fountain Valley, California, United States
• Clinical Trials & Research Associates, Inc. — Montebello, California, United States
• San Diego Hospice & Palliative Care — San Diego, California, United States
• Pacific Clinical Research — Santa Monica, California, United States
• Lovelace Scientific Resources — Miami, Florida, United States
• Gulf Coast Pain Specialists — Pensacola, Florida, United States
• Hematology Oncology Associates of Treasure Coast — Port Saint Lucie, Florida, United States
• Center for Prospective Outcome — Marietta, Georgia, United States
• Iowa Pain Management Clinic, PC — Des Moines, Iowa, United States
• Donald Berdeaux — Great Falls, Montana, United States
• Great Falls Clinic, LLP — Great Falls, Montana, United States
• Southern Nevada Cancer Research — Las Vegas, Nevada, United States
• NYU Pain Management Center — New York, New York, United States
• Research Across America — New York, New York, United States
• Brody School of Medicine — Greenville, North Carolina, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Charleston Hematology Oncology, PA — Charleston, South Carolina, United States
• University of Rochester — San Antonio, Texas, United States
• Lifetree Clinical Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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