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
ClinicalTrials.gov 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
Diabetic Neuropathies
Drug: OraVescent Fentanyl
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00228605

  Show 38 Study Locations
Sponsors and Collaborators
Study Director: Gwendolyn Neibler, DO Cephalon
  More Information

ClinicalTrials.gov Identifier: NCT00228605     History of Changes
Other Study ID Numbers: C25608/3040/BP/US 
Study First Received: September 27, 2005
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
Sudden Pain
low back pain
neuropathic pain
osteoarthritis pain
chronic headache
diabetic peripheral neuropathy

Additional relevant MeSH terms:
Breakthrough Pain
Diabetic Neuropathies
Low Back Pain
Back Pain
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Rheumatic Diseases
Signs and Symptoms
Adjuvants, Anesthesia
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents

ClinicalTrials.gov processed this record on May 26, 2016