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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00228605
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : May 9, 2014
Information provided by:
Teva Pharmaceutical Industries

Brief 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Migraine Diabetic Neuropathies Osteoarthritis Drug: OraVescent Fentanyl Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2005
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Assess the patients' quality of life through questionnaires
  2. Assess the patients' overall medication preferences
  3. Assess the patients' overall medication performance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00228605

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Sponsors and Collaborators
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Study Director: Gwendolyn Neibler, DO Cephalon

Layout table for additonal information Identifier: NCT00228605     History of Changes
Other Study ID Numbers: C25608/3040/BP/US
First Posted: September 29, 2005    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014
Keywords provided by Teva Pharmaceutical Industries:
Sudden Pain
low back pain
neuropathic pain
osteoarthritis pain
chronic headache
diabetic peripheral neuropathy
Additional relevant MeSH terms:
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Migraine Disorders
Diabetic Neuropathies
Back Pain
Low Back Pain
Breakthrough Pain
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents