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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228605
• Other study ID #: C25608/3040/BP/US
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2005
• Last updated: May 8, 2014
• Start date: March 2005
• Est. completion date: May 2007

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breakthrough Pain
• Diabetic Neuropathies
• Low Back Pain
• Migraine
• Osteoarthritis

Intervention

Drug:
• OraVescent Fentanyl

Locations

Country	Name	City	State
United States	Advent Clinical Research Centers, Inc.	Atlanta	Georgia
United States	Center for Prospective Outcome Studies, Inc.	Atlanta	Georgia
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Northshore University Hospital	Beth Page	New York
United States	Orthopedic Health Care	Boise	Idaho
United States	Brigham Women's Hospital, Attn: Pain Trials Center	Boston	Massachusetts
United States	MedSearch	Calera	Alabama
United States	Lynn Institute of the Rockies	Colorado Springs	Colorado
United States	Radiant Research-Daytona Beach	Daytona Beach	Florida
United States	Iowa Pain Management Clinic, PC	Des Moines	Iowa
United States	Medisphere Medical Research Center, LLC	Evansville	Indiana
United States	Tri-State Arthritis & Rheumatology Center, LLC	Evansville	Indiana
United States	Clinical Research Consultants, Inc.	Hoover	Alabama
United States	NEA Clinic	Jonesboro	Arkansas
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Center for Prospective Outcome Studies, Inc.	Marietta	Georgia
United States	Southern Oregon Health & Wellness	Medford	Oregon
United States	Healthstar Physicians	Morristown	Tennessee
United States	NYU Pain Management Center	New York	New York
United States	Research Across America	New York	New York
United States	The Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Mid-America Physiatrists, PA	Overland Park	Kansas
United States	Arizona Research Center	Phoenix	Arizona
United States	Capital Clinical Research Associates, LLC	Rockville	Maryland
United States	North Fulton Regional Hospital Pain Center	Roswell	Georgia
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Lifetree Clinical Research	Salt Lake City	Utah
United States	Radiant Research	Salt Lake City	Utah
United States	Carmen Research	Smyrna	Georgia
United States	Pain Management Center	South Burlington	Vermont
United States	Rowan Research	Spokane	Washington
United States	Medex Healthcare Research Center	St. Louis	Missouri
United States	Radiant Research - St. Louis	St. Louis	Missouri
United States	Advent Clinical Research Centers, Inc.	St. Petersburg	Florida
United States	Biopharma Research Associates	Sugar Land	Texas
United States	MedVadis Research	Wellesley Hills	Massachusetts
United States	Clinical Research Center of Reading, LLP	West Reading	Pennsylvania
United States	Gold Coast Research	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients
Secondary	Assess the patients' quality of life through questionnaires
Secondary	Assess the patients' overall medication preferences
Secondary	Assess the patients' overall medication performance