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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


Phase 3
18 Years
80 Years
Not Enrolling
Both
Low Back Pain, Migraine, Diabetic Neuropathies, Osteoarthritis

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Gwendolyn Neibler, DO

Investigator Role:

Study Director

Investigator Affiliation:

Cephalon

Authority:

United States: Food and Drug Administration

Study ID:

C25608/3040/BP/US

NCT ID:

NCT00228605

Start Date:

March 2005

Completion Date:

May 2007

Related Keywords:

  • Low Back Pain
  • Migraine
  • Diabetic Neuropathies
  • Osteoarthritis
  • Pain
  • Sudden Pain
  • Flares
  • noncancer
  • low back pain
  • neuropathic pain
  • osteoarthritis pain
  • migraine
  • chronic headache
  • diabetic peripheral neuropathy
  • Back Pain
  • Diabetic Neuropathies
  • Low Back Pain
  • Osteoarthritis
  • Migraine Disorders

Name

Location
Huntsman Cancer Institute Salt Lake City, Utah  84112
Clinical Research Consultants, Inc. Hoover, Alabama  35216
Medisphere Medical Research Center, LLC Evansville, Indiana  47714
NYU Pain Management Center New York, New York  10016
Lifetree Clinical Research Salt Lake City, Utah  84106
NEA Clinic Jonesboro, Arkansas  72401
Iowa Pain Management Clinic, PC Des Moines, Iowa  50265
Research Across America New York, New York  10021
MedSearch Calera, Alabama  35040
Arizona Research Center Phoenix, Arizona  85023
Lynn Institute of the Rockies Colorado Springs, Colorado  80909
Radiant Research-Daytona Beach Daytona Beach, Florida  32114
Advent Clinical Research Centers, Inc. St. Petersburg, Florida  33703
Gold Coast Research Weston, Florida  33331
Advent Clinical Research Centers, Inc. Atlanta, Georgia  30342
Center for Prospective Outcome Studies, Inc. Atlanta, Georgia  30327
North Fulton Regional Hospital Pain Center Roswell, Georgia  30076
Carmen Research Smyrna, Georgia  30080
Orthopedic Health Care Boise, Idaho  83702
Tri-State Arthritis & Rheumatology Center, LLC Evansville, Indiana  47714
Mid-America Physiatrists, PA Overland Park, Kansas  66211
Capital Clinical Research Associates, LLC Rockville, Maryland  20852
Brigham Women's Hospital, Attn: Pain Trials Center Boston, Massachusetts  02115
MedVadis Research Wellesley Hills, Massachusetts  02481-2106
Medex Healthcare Research Center St. Louis, Missouri  63108
Radiant Research - St. Louis St. Louis, Missouri  63141
Clinical Research Center of Nevada Las Vegas, Nevada  89104
Northshore University Hospital Beth Page, New York  11714
The Lynn Health Science Institute Oklahoma City, Oklahoma  73112
Southern Oregon Health & Wellness Medford, Oregon  97504
Clinical Research Center of Reading, LLP West Reading, Pennsylvania  19611
Healthstar Physicians Morristown, Tennessee  37813
Biopharma Research Associates Sugar Land, Texas  77479
Radiant Research Salt Lake City, Utah  84107
Pain Management Center South Burlington, Vermont  05403
Northwest Clinical Research Center Bellevue, Washington  98004
Rowan Research Spokane, Washington  99207