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

This study has been completed.
Information provided by:
Teva Pharmaceutical Industries Identifier:
First received: September 27, 2005
Last updated: May 8, 2014
Last verified: May 2014
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 Intervention Phase
Low Back Pain Migraine Diabetic Neuropathies Osteoarthritis Drug: OraVescent Fentanyl Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Teva Pharmaceutical Industries:

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

Secondary Outcome Measures:
  • Assess the patients' quality of life through questionnaires
  • Assess the patients' overall medication preferences
  • Assess the patients' overall medication performance

Estimated Enrollment: 500
Study Start Date: March 2005
Study Completion Date: May 2007

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00228605

  Show 38 Study Locations
Sponsors and Collaborators
Study Director: Gwendolyn Neibler, DO Cephalon
  More Information Identifier: NCT00228605     History of Changes
Other Study ID Numbers: C25608/3040/BP/US
Study First Received: September 27, 2005
Last Updated: May 8, 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:
Back Pain
Low Back Pain
Migraine Disorders
Diabetic Neuropathies
Breakthrough Pain
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central 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 processed this record on August 17, 2017