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

Condition(s) targeted: Pain; Cancer

Intervention: OraVescent fentanyl citrate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cephalon

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.

Official title: Multi-Center, Open Label, Long-Term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Tolerability and safety of OraVescent fentanyl when used long-term

Secondary outcome:

Assess the effectiveness of OraVescent fentanyl

Assess the development of incremental tolerance

Detailed 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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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 hematological

malignancy

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

Center for Pain Management, Huntsville, Alabama 35801, United States

Arizona Clinical Research Center, Tucson, Arizona 85712, United States

Outcomes Research International, Tucson, Arizona 85711, United States

Hot Spring Pain Clinic, Hot Springs, Arkansas 71913, United States

Arkansas Cancer Institute, Pine Bluff, Arkansas 71603, United States

Saint Joseph's Mercy Cancer Center, Hot Springs, Arkansas 71913, United States

Saint Joseph's Mercy Cancer Center, Hot Springs, Arkansas 71913, United States

The Cancer Prevention and Treatment Center, Soquel, California 95073, United States

City of Hope National Medical Center, Duarte, California 91010, United States

Northwestern Connecticut Oncology & Hematology Associates, Torrington, Connecticut 06790, United States

Clinical Pharmacology Services, Inc, Tampa, Florida 33617, 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

Florida Medical Clinic, PA, Zephyrhills, Florida 33542, United States

Innovative Medical Research of South Florida, Miami Shores, Florida 33138, United States

Hematology Oncology Associates, Lake Worth, Florida 33461-4710, United States

Palm Beach Research, West Palm Beach, Florida 33409, United States

Gulf Coast Oncology Association, St. Petersburg, Florida 33705, 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

Providence Cancer Institute, Southfield, Michigan 48075, United States

Huron Medical Center, Port Huron, Michigan 48067, United States

Bond Clinic, Inc, Rolla, Missouri 65407, United States

HealthCare Research, LLC, St. Louis, Missouri 63141, United States

Beth Israel Medical Center, New York, New York 10003, United States

North Shore University Hospital, Manhasset, New York 11030, 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

UTHCT (ATTN: Clinical Research), Tyler, Texas 75708, United States

Cancer Care Centers of South Texas, San Antonio, Texas 78229, United States

Palliative Care and Pain Medicine, Salt Lake City, Utah 84157, United States

Great Basin Clinical Research, West Point, Utah 84015, United States

Hunstman Cancer Institute, Salt Lake City, Utah 84112, 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

Starting date: April 2004
Ending date: November 2006
Last updated: May 25, 2007