ClinicalTrials.gg
Sign In
CompletedNCT00228605Updated May 9, 2014

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

A Phase 3 interventional study of OraVescent Fentanyl in Low Back Pain, Migraine and Diabetic Neuropathies, sponsored by Cephalon. Completed at 38 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-05-09.

Sponsored by Cephalon (part of Teva Pharmaceutical Industries, Ltd.) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
500
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Low Back Pain
  • Migraine
  • Diabetic Neuropathies
  • Osteoarthritis

Keywords

  • Pain
  • Sudden Pain
  • Flares
  • noncancer
  • low back pain
  • neuropathic pain
  • osteoarthritis pain
  • migraine
  • chronic headache
  • diabetic peripheral neuropathy
03

In context

Low Back Pain

2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.

This study's enrollment of 500 is above the median of 60 across 2,315 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Cephalon is the lead sponsor of 75 studies on the registry; none are open to participants now.

First submitted before Cephalon became part of Teva Pharmaceutical Industries, Ltd..

Browse Cephalon studies →All Teva Pharmaceutical Industries, Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Chronic pain diagnosis
  • Opioid tolerant
  • Has on average 1-4 breakthrough pain episodes per day

Exclusion criteria

Exclusion Criteria:

  • Drug abuse history
  • Cardiopulmonary disease
  • Monoamine oxidase inhibitors (MAOIs)
  • Expected to have surgery to relieve the pain
05

Study design

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

Interventions

  • DrugOraVescent Fentanyl
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Assess the patients' quality of life through questionnaires

  2. Assess the patients' overall medication preferences

  3. Assess the patients' overall medication performance

07

Study locations

38 sites
  • MedSearch
    Calera, Alabama 35040, United States
  • Clinical Research Consultants, Inc.
    Hoover, Alabama 35216, United States
  • Arizona Research Center
    Phoenix, Arizona 85023, United States
  • NEA Clinic
    Jonesboro, Arkansas 72404, United States
  • Lynn Institute of the Rockies
    Colorado Springs, Colorado 80909, United States
  • Radiant Research-Daytona Beach
    Daytona Beach, Florida 32114, United States
  • Advent Clinical Research Centers, Inc.
    St. Petersburg, Florida 33703, United States
  • Gold Coast Research
    Weston, Florida 33331, United States
  • Center for Prospective Outcome Studies, Inc.
    Atlanta, Georgia 30327, United States
  • Advent Clinical Research Centers, Inc.
    Atlanta, Georgia 30342, United States
  • Center for Prospective Outcome Studies, Inc.
    Marietta, Georgia 30060, United States
  • North Fulton Regional Hospital Pain Center
    Roswell, Georgia 30076, United States
  • Carmen Research
    Smyrna, Georgia 30080, United States
  • Orthopedic Health Care
    Boise, Idaho 83702, United States
  • Medisphere Medical Research Center, LLC
    Evansville, Indiana 47714, United States
  • Tri-State Arthritis & Rheumatology Center, LLC
    Evansville, Indiana 47714, United States
  • Iowa Pain Management Clinic, PC
    Des Moines, Iowa 50265, United States
  • Mid-America Physiatrists, PA
    Overland Park, Kansas 66211, United States
  • Capital Clinical Research Associates, LLC
    Rockville, Maryland 20852, United States
  • Brigham Women's Hospital, Attn: Pain Trials Center
    Boston, Massachusetts 02115, United States
  • MedVadis Research
    Wellesley Hills, Massachusetts 02481-2106, United States
  • Medex Healthcare Research Center
    St Louis, Missouri 63108, United States
  • Radiant Research - St. Louis
    St Louis, Missouri 63141, United States
  • Clinical Research Center of Nevada
    Las Vegas, Nevada 89104, United States
  • Northshore University Hospital
    Bethpage, New York 11714, United States
  • NYU Pain Management Center
    New York, New York 10016, United States
  • Research Across America
    New York, New York 10022, United States
  • The Lynn Health Science Institute
    Oklahoma City, Oklahoma 73112, United States
  • Southern Oregon Health & Wellness
    Medford, Oregon 97504, United States
  • Clinical Research Center of Reading, LLP
    West Reading, Pennsylvania 19611, United States
  • Healthstar Physicians
    Morristown, Tennessee 37813, United States
  • Biopharma Research Associates
    Sugar Land, Texas 77479, United States
  • Lifetree Clinical Research
    Salt Lake City, Utah 84106, United States
  • Radiant Research
    Salt Lake City, Utah 84107, United States
  • Huntsman Cancer Institute
    Salt Lake City, Utah 84112, United States
  • Pain Management Center
    South Burlington, Vermont 05403, United States
  • Northwest Clinical Research Center
    Bellevue, Washington 98004, United States
  • Rowan Research
    Spokane, Washington 99207, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00228605
Lead sponsor
Cephalon
First posted
Sep 29, 2005
Start date
Mar 2005
Completion
May 2007
Last update
May 9, 2014

Study contacts

Gwendolyn Neibler, DO
study director · Cephalon
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Low Back Pain →

Other studies from this sponsor

Cephalon →

Start the discussion