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

This study has been completed.

First Received: September 27, 2005 Last Updated: November 9, 2007 History of Changes

Sponsor:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00228605

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Back Pain Diabetic Nerve Problems Headache Migraine Osteoarthritis

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Cephalon:

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

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

Study ID Numbers:	C25608/3040/BP/US
Study First Received:	September 27, 2005
Last Updated:	November 9, 2007
ClinicalTrials.gov Identifier:	NCT00228605 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cephalon:

Pain
Sudden Pain
Flares
noncancer
low back pain

neuropathic pain
osteoarthritis pain
migraine
chronic headache
diabetic peripheral neuropathy

Additional relevant MeSH terms:

Fentanyl
Osteoarthritis
Physiological Effects of Drugs
Anesthetics
Pain
Headache Disorders, Primary
Brain Diseases
Headache Disorders
Signs and Symptoms
Neuromuscular Diseases
Musculoskeletal Diseases
Sensory System Agents
Migraine Disorders
Therapeutic Uses
Arthritis

Analgesics
Analgesics, Opioid
Diabetes Complications
Anesthetics, Intravenous
Diabetic Neuropathies
Joint Diseases
Nervous System Diseases
Diabetes Mellitus
Central Nervous System Depressants
Low Back Pain
Endocrine System Diseases
Central Nervous System Diseases
Narcotics
Rheumatic Diseases
Back Pain

ClinicalTrials.gov processed this record on February 08, 2010