CClinicalTrials.gg
CompletedNCT00105937Updated Jun 29, 2012

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

A Phase 3 interventional study of OraVescent fentanyl citrate in Pain and Cancer, sponsored by Cephalon. Completed at 43 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-06-29.

Sponsored by Cephalon · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pain
  • Cancer

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Keywords

  • Cancer
  • Pain
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants

Interventions

  • DrugOraVescent fentanyl citrate
05

What researchers measure

Primary outcomes

  1. Tolerability and safety of OraVescent fentanyl when used long-term

Secondary outcomes

  1. Assess the effectiveness of OraVescent fentanyl

  2. Assess the development of incremental tolerance

06

Study locations

43 sites
  • Center for Pain Management
    Huntsville, Alabama 35801, United States
  • Outcomes Research International
    Tucson, Arizona 85711, United States
  • Arizona Clinical Research Center
    Tucson, Arizona 85712, United States
  • Hot Spring Pain Clinic
    Hot Springs, Arkansas 71913, United States
  • Saint Joseph's Mercy Cancer Center
    Hot Springs, Arkansas 71913, United States
  • Arkansas Cancer Institute
    Pine Bluff, Arkansas 71603, United States
  • City of Hope National Medical Center
    Duarte, California 91010, United States
  • The Cancer Prevention and Treatment Center
    Soquel, California 95073, United States
  • Northwestern Connecticut Oncology & Hematology Associates
    Torrington, Connecticut 06790, United States
  • Florida Institute of Medical Research
    Jacksonville, Florida 32207, United States
  • University of Florida Shands Cancer Center at Jacksonville
    Jacksonville, Florida 32209, United States
  • Hematology Oncology Associates
    Lake Worth, Florida 33461-4710, United States
  • Innovative Medical Research of South Florida
    Miami Shores, Florida 33138, United States
  • Gulf Coast Oncology Association
    St. Petersburg, Florida 33705, United States
  • Clinical Pharmacology Services, Inc
    Tampa, Florida 33617, United States
  • Palm Beach Research
    West Palm Beach, Florida 33409, United States
  • Florida Medical Clinic, PA
    Zephyrhills, Florida 33542, United States
  • Southeastern Gynecologic Oncology, LLC
    Atlanta, Georgia 30342, United States
  • North Shore Cancer Research Association
    Skokie, Illinois 60076, United States
  • Kentucky Cancer Clinic
    Hazard, Kentucky 41701, United States
  • Southwest Oncology Associates
    Lafayette, Louisiana 70503, United States
  • Hematology and Oncology Specialists
    New Orleans, Louisiana 70115, United States
  • St. Agnes Healthcare
    Baltimore, Maryland 21229, United States
  • Huron Medical Center
    Port Huron, Michigan 48067, United States
  • Providence Cancer Institute
    Southfield, Michigan 48075, United States
  • Bond Clinic, Inc
    Rolla, Missouri 65407, United States
  • HealthCare Research, LLC
    St. Louis, Missouri 63141, United States
  • North Shore University Hospital
    Manhasset, New York 11030, United States
  • Beth Israel Medical Center
    New York, New York 10003, United States
  • The Center for Clinical Research, LLC
    Winston-Salem, North Carolina 27103, United States
  • PETC Research Group, Inc.
    Tulsa, Oklahoma 74137, United States
  • Oncology Associates of Oregon
    Eugene, Oregon 97401, United States
  • Allegheny Pain Management, PC
    Altoona, Pennsylvania 16601, United States
  • St. Mary Medical Center
    Langhorne, Pennsylvania 19047, United States
  • Mohamed Haq
    Pasadena, Texas 77504, United States
  • Cancer Care Centers of South Texas
    San Antonio, Texas 78229, United States
  • UTHCT (ATTN: Clinical Research)
    Tyler, Texas 75708, United States
  • Hunstman Cancer Institute
    Salt Lake City, Utah 84112, United States
  • Palliative Care and Pain Medicine
    Salt Lake City, Utah 84157, United States
  • Great Basin Clinical Research
    West Point, Utah 84015, United States
  • Cancer Outreach Associates, PC
    Abingdon, Virginia 24211, United States
  • MedSource Inc
    Richmond, Virginia 23229, United States
  • University of Wisconsin Medical School
    Madison, Wisconsin 53792-5669, United States
07

Registry details

Key details

Study ID
NCT00105937
Lead sponsor
Cephalon
First posted
Mar 21, 2005
Start date
Apr 2004
Completion
Nov 2006
Last update
Jun 29, 2012
View the source record on ClinicalTrials.gov ↗

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