Evaluating the Safety and Tolerability of OraVescent Fentanyl for Opioid Tolerant Patients With Noncancer Related Breakthrough Pain

Condition(s) targeted: Low Back Pain; Migraine; Diabetic Neuropathies; Osteoarthritis

Intervention: OraVescent Fentanyl (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cephalon

Official(s) and/or principal investigator(s):
Gwendolyn Neibler, DO, Study Director, Affiliation: Cephalon

The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl for the potential treatment of breakthrough pain episodes in patients who have chronic noncancer pain.

Official title: An Open-Label 12 Month Study to Evaluate the Safety, Tolerability and Efficacy of OraVescent Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Noncancer Pain

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

Primary outcome: Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients

Secondary outcome:

Assess the patients' quality of life through questionnaires

Assess the patients' overall medication preferences

Assess the patients' overall medication performance

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

Criteria:

Inclusion Criteria:

- Chronic pain diagnosis

- Opioid tolerant

- Has on average 1-4 breakthrough pain episodes per day

Exclusion Criteria:

- Drug abuse history

- Cardiopulmonary disease

- Monoamine oxidase inhibitors (MAOIs)

- Expected to have surgery to relieve the pain

Clinical Research Consultants, Inc., Hoover, Alabama 35216, United States

MedSearch, Calera, Alabama 35040, United States

Arizona Research Center, Phoenix, Arizona 85023, United States

NEA Clinic, Jonesboro, Arkansas 72404, United States

Lynn Institute of the Rockies, Colorado Springs, Colorado 80909, United States

Advent Clinical Research Centers, Inc., St. Petersburg, Florida 33703, United States

Radiant Research-Daytona Beach, Daytona Beach, Florida 32114, United States

Gold Coast Research, Weston, Florida 33331, United States

Advent Clinical Research Centers, Inc., Atlanta, Georgia 30342, United States

North Fulton Regional Hospital Pain Center, Roswell, Georgia 30076, United States

Carmen Research, Smyrna, Georgia 30080, United States

Center for Prospective Outcome Studies, Inc., Marietta, Georgia 30060, United States

Center for Prospective Outcome Studies, Inc., Atlanta, Georgia 30327, United States

Orthopedic Health Care, Boise, Idaho 83702, United States

Medisphere Medical Research Center, LLC, Evansville, Indiana 47714, United States

Tri-State Arthritis & Rheumatology Center, LLC, Evansville, Indiana 47714, United States

Iowa Pain Management Clinic, PC, Des Moines, Iowa 50265, United States

Mid-America Physiatrists, PA, Overland Park, Kansas 66211, United States

Capital Clinical Research Associates, LLC, Rockville, Maryland 20852, United States

Brigham Women's Hospital, Attn: Pain Trials Center, Boston, Massachusetts 02115, United States

MedVadis Research, Wellesley Hills, Massachusetts 02481-2106, United States

Medex Healthcare Research Center, St. Louis, Missouri 63108, United States

Radiant Research - St. Louis, St. Louis, Missouri 63141, United States

Clinical Research Center of Nevada, Las Vegas, Nevada 89104, United States

Research Across America, New York, New York 10022, United States

Northshore University Hospital, Beth Page, New York 11714, United States

NYU Pain Management Center, New York, New York 10016, United States

The Lynn Health Science Institute, Oklahoma City, Oklahoma 73112, United States

Southern Oregon Health & Wellness, Medford, Oregon 97504, United States

Clinical Research Center of Reading, LLP, West Reading, Pennsylvania 19611, United States

Healthstar Physicians, Morristown, Tennessee 37813, United States

Biopharma Research Associates, Sugar Land, Texas 77479, United States

Radiant Research, Salt Lake City, Utah 84107, United States

Lifetree Clinical Research, Salt Lake City, Utah 84106, United States

Huntsman Cancer Institute, Salt Lake City, Utah 84112, United States

Pain Management Center, South Burlington, Vermont 05403, United States

Northwest Clinical Research Center, Bellevue, Washington 98004, United States

Rowan Research, Spokane, Washington 99207, United States

Starting date: March 2005
Ending date: May 2007
Last updated: November 9, 2007