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

Last updated: June 27, 2012
Sponsor: Cephalon
Overall Status: Completed

Phase

3

Condition

Pain

Cancer

Treatment

N/A

Clinical Study ID

NCT00105937
099-15
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 hematologicalmalignancy

Exclusion

Exclusion Criteria:

  • 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

Study Design

Total Participants: 300
Study Start date:
April 01, 2004
Estimated Completion Date:
November 30, 2006

Study Description

The objective of this study is to determine the tolerability and safety of OraVescent fentanyl when used long term to relieve breakthrough pain in opioid tolerant cancer patients.

Connect with a study center

  • Center for Pain Management

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Arizona Clinical Research Center

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Outcomes Research International

    Tucson, Arizona 85711
    United States

    Site Not Available

  • Hot Spring Pain Clinic

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Saint Joseph's Mercy Cancer Center

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Arkansas Cancer Institute

    Pine Bluff, Arkansas 71603
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • The Cancer Prevention and Treatment Center

    Soquel, California 95073
    United States

    Site Not Available

  • Northwestern Connecticut Oncology & Hematology Associates

    Torrington, Connecticut 06790
    United States

    Site Not Available

  • Florida Institute of Medical Research

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • University of Florida Shands Cancer Center at Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Hematology Oncology Associates

    Lake Worth, Florida 33461-4710
    United States

    Site Not Available

  • Innovative Medical Research of South Florida

    Miami Shores, Florida 33138
    United States

    Site Not Available

  • Gulf Coast Oncology Association

    St. Petersburg, Florida 33705
    United States

    Site Not Available

  • Clinical Pharmacology Services, Inc

    Tampa, Florida 33617
    United States

    Site Not Available

  • Palm Beach Research

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Florida Medical Clinic, PA

    Zephyrhills, Florida 33542
    United States

    Site Not Available

  • Southeastern Gynecologic Oncology, LLC

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • North Shore Cancer Research Association

    Skokie, Illinois 60076
    United States

    Site Not Available

  • Kentucky Cancer Clinic

    Hazard, Kentucky 41701
    United States

    Site Not Available

  • Southwest Oncology Associates

    Lafayette, Louisiana 70503
    United States

    Site Not Available

  • Hematology and Oncology Specialists

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • St. Agnes Healthcare

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • Huron Medical Center

    Port Huron, Michigan 48067
    United States

    Site Not Available

  • Providence Cancer Institute

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Bond Clinic, Inc

    Rolla, Missouri 65407
    United States

    Site Not Available

  • HealthCare Research, LLC

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Beth Israel Medical Center

    New York, New York 10003
    United States

    Site Not Available

  • The Center for Clinical Research, LLC

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • PETC Research Group, Inc.

    Tulsa, Oklahoma 74137
    United States

    Site Not Available

  • Oncology Associates of Oregon

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Allegheny Pain Management, PC

    Altoona, Pennsylvania 16601
    United States

    Site Not Available

  • St. Mary Medical Center

    Langhorne, Pennsylvania 19047
    United States

    Site Not Available

  • Mohamed Haq

    Pasadena, Texas 77504
    United States

    Site Not Available

  • Cancer Care Centers of South Texas

    San Antonio, Texas 78229
    United States

    Site Not Available

  • UTHCT (ATTN: Clinical Research)

    Tyler, Texas 75708
    United States

    Site Not Available

  • Hunstman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Palliative Care and Pain Medicine

    Salt Lake City, Utah 84157
    United States

    Site Not Available

  • Great Basin Clinical Research

    West Point, Utah 84015
    United States

    Site Not Available

  • Cancer Outreach Associates, PC

    Abingdon, Virginia 24211
    United States

    Site Not Available

  • MedSource Inc

    Richmond, Virginia 23229
    United States

    Site Not Available

  • University of Wisconsin Medical School

    Madison, Wisconsin 53792-5669
    United States

    Site Not Available

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