Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain

NCT ID: NCT00343733

Last Updated: 2014-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-07-31

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of OraVescent fentanyl treatment compared to placebo treatment monthly over a 12-week treatment period in alleviating breakthrough pain (BTP) in opioid-tolerant patients with noncancer-related chronic pain.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

OraVescent Fentanyl

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients are included in the study if all of the following criteria are met:

• The patient is willing to provide written informed consent to participate in this study.
• The patient is 18 through 80 years of age.
• Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive [oral, transdermal, implanted, and injected contraceptives must be used in conjunction with a barrier method], or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study.
• The patient has chronic pain of at least 3 months' duration associated with any of the following conditions: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia (documented diagnosis), chronic pancreatitis, or osteoarthritis. Other chronic painful conditions may be evaluated for entry upon discussion with, and written approval from, the Cephalon Medical Monitor.
• The patient is currently using 1 of the following: at least 60 mg of oral morphine/day, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oxycodone/day, or at least 8 mg of hydromorphone/day, or an equianalgesic dose of another opioid/day as a stable dose of ATC therapy for at least the previous 30 days prior to enrollment in the study.
• The patient reports an average pain intensity score, over the prior 24 hours, of 6 or less (0=no pain through 10=worst pain) for his/her chronic pain.
• The patient experiences, on average, 1 to 4 BTP episodes (defined as temporary flares of severe or excruciating pain) per day while taking ATC opioid therapy, and on average, the duration of each BTP episode is less than 4 hours.
• The patient currently uses opioid therapy for alleviation of BTP episodes, occurring at the location of the chronic pain, and achieves at least partial relief.
• The patient is able to effectively self-administer the study drug and complete the electronic diary.

Exclusion Criteria

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

• The patient has uncontrolled or rapidly escalating pain as determined by the investigator (ie, the ATC therapy may be expected to change between the first and last treatments with study drug), or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug.
• The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in the study drug.
• The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse.
• The patient has cardiopulmonary disease that would, in the opinion of the investigator, significantly increase the risk of treatment with potent synthetic opioids.
• The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.
• The patient is expected to have surgery during the study and it is anticipated that the surgery will alleviate the patient's pain.
• The patient has had therapy before study drug treatment that, in the opinion of the investigator, could alter pain or response to pain medication.
• The patient is pregnant or lactating.
• The patient has participated in a previous study with OraVescent fentanyl.
• The patient has participated in a study involving an investigational drug in the previous 30 days.
• The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
• The patient has any other medical condition or is receiving concomitant medication/therapy (eg, regional nerve block) that would, in the opinion of the investigator, compromise the patient's safety or compliance with the study protocol, or compromise collected data.
• The patient is involved in active litigation in regard to the chronic pain currently being treated.
• The patient has a positive urine drug screen (UDS) for a medication not prescribed by the physician currently treating the chronic pain.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cephalon

INDUSTRY

Sponsor Role: lead

Locations

Hot Springs Pain Clinic

Hot Springs, Arkansas, United States

Samaritan Center for Medical

Los Gatos, California, United States

Pacific Neuroscience Medical Group, Inc.

Oxnard, California, United States

Centre for Rheumatology

Fort Lauderdale, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Atlas Research

Orlando, Florida, United States

Gold Coast Research, LLC

Plantation, Florida, United States

Comprehensive Pain Care, PC

Marietta, Georgia, United States

Drug Studies America

Marietta, Georgia, United States

Best Clinical Trials, Inc.

New Orleans, Louisiana, United States

Best Clinical Trials, LLC

New Orleans, Louisiana, United States

Brigham Women's Hospital

Boston, Massachusetts, United States

Pain Management Associates

Independence, Missouri, United States

Montana Neuroscience Institute

Missoula, Montana, United States

Lovelace Scientific Resources

Albuquerque, New Mexico, United States

Five Towns Neuroscience Research

Lawrence, New York, United States

PharmQuest

Greensboro, North Carolina, United States

Center for Clinical Research

Winston-Salem, North Carolina, United States

Legacy Emanuel Pain Management, PC

Portland, Oregon, United States

Clinical Research Center

West Reading, Pennsylvania, United States

Advanced Pain Management

Virginia Beach, Virginia, United States

Countries

United States

Other Identifiers

C25608/3052/BP/US

Identifier Type: -

Identifier Source: org_study_id