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

June 27, 2012 updated by: Cephalon

Multi-center, Open Label, Long-term Study of OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

300

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
      • Huntsville, Alabama, United States, 35801
        • Center for Pain Management
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Center
      • Tucson, Arizona, United States, 85711
        • Outcomes Research International
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Saint Joseph's Mercy Cancer Center
      • Hot Springs, Arkansas, United States, 71913
        • Hot Spring Pain Clinic
      • Pine Bluff, Arkansas, United States, 71603
        • Arkansas Cancer Institute
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Soquel, California, United States, 95073
        • The Cancer Prevention and Treatment Center
    • Connecticut
      • Torrington, Connecticut, United States, 06790
        • Northwestern Connecticut Oncology & Hematology Associates
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Florida Institute of Medical Research
      • Jacksonville, Florida, United States, 32209
        • University of Florida Shands Cancer Center at Jacksonville
      • Lake Worth, Florida, United States, 33461-4710
        • Hematology Oncology Associates
      • Miami Shores, Florida, United States, 33138
        • Innovative Medical Research of South Florida
      • St. Petersburg, Florida, United States, 33705
        • Gulf Coast Oncology Association
      • Tampa, Florida, United States, 33617
        • Clinical Pharmacology Services, Inc
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, PA
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Southeastern Gynecologic Oncology, LLC
    • Illinois
      • Skokie, Illinois, United States, 60076
        • North Shore Cancer Research Association
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Kentucky Cancer Clinic
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Southwest Oncology Associates
      • New Orleans, Louisiana, United States, 70115
        • Hematology and Oncology Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • St. Agnes Healthcare
    • Michigan
      • Port Huron, Michigan, United States, 48067
        • Huron Medical Center
      • Southfield, Michigan, United States, 48075
        • Providence Cancer Institute
    • Missouri
      • Rolla, Missouri, United States, 65407
        • Bond Clinic, Inc
      • St. Louis, Missouri, United States, 63141
        • Healthcare Research, LLC
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research, LLC
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • PETC Research Group, Inc.
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oncology Associates of Oregon
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • Allegheny Pain Management, PC
      • Langhorne, Pennsylvania, United States, 19047
        • St. Mary Medical Center
    • Texas
      • Pasadena, Texas, United States, 77504
        • Mohamed Haq
      • San Antonio, Texas, United States, 78229
        • Cancer Care Centers of South Texas
      • Tyler, Texas, United States, 75708
        • UTHCT (ATTN: Clinical Research)
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Hunstman Cancer Institute
      • Salt Lake City, Utah, United States, 84157
        • Palliative Care and Pain Medicine
      • West Point, Utah, United States, 84015
        • Great Basin Clinical Research
    • Virginia
      • Abingdon, Virginia, United States, 24211
        • Cancer Outreach Associates, Pc
      • Richmond, Virginia, United States, 23229
        • MedSource Inc
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-5669
        • University of Wisconsin Medical School

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:

  • 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

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
Tolerability and safety of OraVescent fentanyl when used long-term

Secondary Outcome Measures

Outcome Measure
Assess the effectiveness of OraVescent fentanyl
Assess the development of incremental tolerance

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

April 1, 2004

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

March 18, 2005

First Submitted That Met QC Criteria

March 18, 2005

First Posted (Estimate)

March 21, 2005

Study Record Updates

Last Update Posted (Estimate)

June 29, 2012

Last Update Submitted That Met QC Criteria

June 27, 2012

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 099-15

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.

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