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

This study has been completed.

First Received on September 27, 2005. Last Updated on 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 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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

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

ClinicalTrials.gov Identifier:	NCT00228605 History of Changes
Other Study ID Numbers:	C25608/3040/BP/US
Study First Received:	September 27, 2005
Last Updated:	November 9, 2007
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:

Back Pain
Diabetic Neuropathies
Low Back Pain
Osteoarthritis
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Fentanyl
Analgesics, Opioid
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 24, 2012