MedPath

Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Phase 3
Completed
Conditions
Pain
Cancer
Registration Number
NCT00105287
Lead Sponsor
Cephalon
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
Inclusion Criteria
  • 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
Exclusion Criteria
  • Opioid or fentanyl intolerance
  • Sleep apnea or active brain metastases with increased intracranial pressure
  • COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (26)

Advanced Clinical Research Institute

🇺🇸

Anaheim, California, United States

Lehigh Valley Hospital

🇺🇸

Allentown, Pennsylvania, United States

University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

Compassionate Cancer Center

🇺🇸

Fountain Valley, California, United States

Great Falls Clinic, LLP

🇺🇸

Great Falls, Montana, United States

Southern Nevada Cancer Research

🇺🇸

Las Vegas, Nevada, United States

Donald Berdeaux

🇺🇸

Great Falls, Montana, United States

San Diego Hospice & Palliative Care

🇺🇸

San Diego, California, United States

Center for Prospective Outcome

🇺🇸

Marietta, Georgia, United States

Lovelace Scientific Resources

🇺🇸

Miami, Florida, United States

Hematology Oncology Associates of Treasure Coast

🇺🇸

Port St. Lucie, Florida, United States

Research Across America

🇺🇸

New York, New York, United States

Cullman Oncology and Hematology

🇺🇸

Cullman, Alabama, United States

Pacific Cancer Medical Center

🇺🇸

Anaheim, California, United States

Gulf Coast Pain Specialists

🇺🇸

Pensacola, Florida, United States

Compassionate Cancer Care Medical Group

🇺🇸

Corona, California, United States

Clinical Trials & Research Associates, Inc.

🇺🇸

Montebello, California, United States

Pacific Clinical Research

🇺🇸

Santa Monica, California, United States

Brody School of Medicine

🇺🇸

Greenville, North Carolina, United States

NYU Pain Management Center

🇺🇸

New York, New York, United States

Gabrail Cancer Center

🇺🇸

Canton, Ohio, United States

Cache Valley Cancer Treatment and Research Clinic, Inc.

🇺🇸

West Point, Utah, United States

Iowa Pain Management Clinic, PC

🇺🇸

Des Moines, Iowa, United States

Lifetree Clinical Research

🇺🇸

Salt Lake City, Utah, United States

Charleston Hematology Oncology, PA

🇺🇸

Charleston, South Carolina, United States

University of Rochester

🇺🇸

San Antonio, Texas, United States

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