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

History of Changes

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 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:

Drug Information available for: Fentanyl Fentanyl citrate

U.S. FDA Resources

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 (Adult, Senior)
Sexes Eligible for Study:	All
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


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

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:


Osteoarthritis Back Pain Low Back Pain Migraine Disorders Diabetic Neuropathies Breakthrough Pain Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Pain 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 Fentanyl Analgesics, Opioid Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents

ClinicalTrials.gov processed this record on July 18, 2017

To Top