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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00228605
First received: September 27, 2005
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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
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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00228605

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

No publications provided

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

Additional relevant MeSH terms:
Back Pain
Breakthrough Pain
Diabetic Neuropathies
Low Back Pain
Osteoarthritis
Arthritis
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Joint Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Rheumatic Diseases
Signs and Symptoms
Fentanyl
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014