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

May 8, 2014 updated by: Cephalon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Calera, Alabama, United States, 35040
        • MedSearch
      • Hoover, Alabama, United States, 35216
        • Clinical Research Consultants, Inc.
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
    • Arkansas
      • Jonesboro, Arkansas, United States, 72404
        • NEA Clinic
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Lynn Institute Of The Rockies
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Radiant Research-Daytona Beach
      • St. Petersburg, Florida, United States, 33703
        • Advent Clinical Research Centers, Inc.
      • Weston, Florida, United States, 33331
        • Gold Coast Research
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Center for Prospective Outcome Studies, Inc.
      • Atlanta, Georgia, United States, 30342
        • Advent Clinical Research Centers, Inc.
      • Marietta, Georgia, United States, 30060
        • Center for Prospective Outcome Studies, Inc.
      • Roswell, Georgia, United States, 30076
        • North Fulton Regional Hospital Pain Center
      • Smyrna, Georgia, United States, 30080
        • Carmen Research
    • Idaho
      • Boise, Idaho, United States, 83702
        • Orthopedic Health Care
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Medisphere Medical Research Center, Llc
      • Evansville, Indiana, United States, 47714
        • Tri-State Arthritis & Rheumatology Center, LLC
    • Iowa
      • Des Moines, Iowa, United States, 50265
        • Iowa Pain Management Clinic, PC
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Mid-America Physiatrists, PA
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Capital Clinical Research Associates, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham Women's Hospital, Attn: Pain Trials Center
      • Wellesley Hills, Massachusetts, United States, 02481-2106
        • MedVadis Research
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Medex Healthcare Research Center
      • St. Louis, Missouri, United States, 63141
        • Radiant Research - St. Louis
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Clinical Research Center Of Nevada
    • New York
      • Beth Page, New York, United States, 11714
        • Northshore University Hospital
      • New York, New York, United States, 10022
        • Research Across America
      • New York, New York, United States, 10016
        • NYU Pain Management Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • The Lynn Health Science Institute
    • Oregon
      • Medford, Oregon, United States, 97504
        • Southern Oregon Health & Wellness
    • Pennsylvania
      • West Reading, Pennsylvania, United States, 19611
        • Clinical Research Center of Reading, LLP
    • Tennessee
      • Morristown, Tennessee, United States, 37813
        • Healthstar Physicians
    • Texas
      • Sugar Land, Texas, United States, 77479
        • Biopharma Research Associates
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
      • Salt Lake City, Utah, United States, 84107
        • Radiant Research
      • Salt Lake City, Utah, United States, 84106
        • Lifetree Clinical Research
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Pain Management Center
    • Washington
      • Bellevue, Washington, United States, 98004
        • Northwest Clinical Research Center
      • Spokane, Washington, United States, 99207
        • Rowan Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Assess the patients' quality of life through questionnaires
Assess the patients' overall medication preferences
Assess the patients' overall medication performance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cephalon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 29, 2005

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C25608/3040/BP/US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Neuropathies

Clinical Trials on OraVescent Fentanyl

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe