Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain

NCT ID: NCT00463047

Last Updated: 2012-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-02-28

Brief Summary

Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic pain.

Conditions

Chronic Pain

Study Design

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

Study Groups

Fentanyl Buccal Tablets (FBT)

This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order).

Group Type: EXPERIMENTAL

Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone

Intervention Type: DRUG

Patients will be randomly assigned in a 1:1 ratio either to titrate immediate-release oxycodone first and to titrate FBT second, or to titrate FBT first and immediate-release oxycodone second, followed by 2 double-blind crossover treatment periods (in randomized order). For the double-blind treatment period of the study involving FBT administration, a patient is randomly assigned to receive FBT at the 200, 400, 600, or 800 mcg strength found to be successful during open-label titration. For the double-blind treatment period of the study to which a patient is randomly assigned to receive immediate-release oxycodone, the patient will receive immediate-release oxycodone at the strength (15, 30, 45, or 60 mg) found to be successful during open-label titration.

Oxycodone

This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order).

Group Type: ACTIVE_COMPARATOR

Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone

Intervention Type: DRUG

Patients will be randomly assigned in a 1:1 ratio either to titrate immediate-release oxycodone first and to titrate FBT second, or to titrate FBT first and immediate-release oxycodone second, followed by 2 double-blind crossover treatment periods (in randomized order). For the double-blind treatment period of the study involving FBT administration, a patient is randomly assigned to receive FBT at the 200, 400, 600, or 800 mcg strength found to be successful during open-label titration. For the double-blind treatment period of the study to which a patient is randomly assigned to receive immediate-release oxycodone, the patient will receive immediate-release oxycodone at the strength (15, 30, 45, or 60 mg) found to be successful during open-label titration.

Interventions

Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone

Patients will be randomly assigned in a 1:1 ratio either to titrate immediate-release oxycodone first and to titrate FBT second, or to titrate FBT first and immediate-release oxycodone second, followed by 2 double-blind crossover treatment periods (in randomized order). For the double-blind treatment period of the study involving FBT administration, a patient is randomly assigned to receive FBT at the 200, 400, 600, or 800 mcg strength found to be successful during open-label titration. For the double-blind treatment period of the study to which a patient is randomly assigned to receive immediate-release oxycodone, the patient will receive immediate-release oxycodone at the strength (15, 30, 45, or 60 mg) found to be successful during open-label titration.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The patient has chronic pain of at least 3 months duration associated with: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain,fibromyalgia, chronic pancreatitis, osteoarthritis,or cancer.
• 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 around-the-clock (ATC) therapy for at least 7 days before administration of the first dose of study drug
• 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 and agree to continued use of this method for the duration of the study.
• Any patient with cancer should have a life expectancy of at least 3 months.
• The patient reports an average Pain Intensity (PI) score, over the prior 24 hours, of 6 or less (0=no pain through 10=pain as bad as you can imagine) for their chronic pain.
• The patient experiences, on average, 1 to 4 breakthrough pain (BTP) episodes 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 must be willing and able to successfully self-administer the study drug,comply with study restrictions, complete the electronic diary, and return to the clinic for scheduled study visits as specified in this protocol.

Exclusion Criteria

• The patient has uncontrolled or rapidly escalating pain as determined by the investigator (i.e., the around-the-clock (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 a recent history (within 5 years) or current evidence of alcohol or other substance abuse.
• The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in either study drug.
• 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 that will impact the patient's chronic pain and/or BTP.
• 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 FBT.
• The patient has participated in a study involving an investigational drug in the prior 30 days.
• The patient is currently using prescription FBT or immediate-release oxycodone for BTP and is unwilling to undergo re-titration.
• 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 could, 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 an illicit drug or a medication not prescribed for him/her or which is not medically explainable.

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

Sponsors

Cephalon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alabama Clinical Therapeutics

Birmingham, Alabama, United States

Birmingham Pain Center

Birmingham, Alabama, United States

Arizona Research Center

Phoenix, Arizona, United States

Desert Pain & Rehab Specialists/Redpoint Research

Phoenix, Arizona, United States

Hope Research Institute

Phoenix, Arizona, United States

Lovelace Scientific Resources, Inc.

Beverly Hills, California, United States

City of Hope National Medical Center

Duarte, California, United States

Samaritan Center for Medical Research, Med. Group

Los Gatos, California, United States

Advanced Diagnostic Pain Treatment Center, PC

New Haven, Connecticut, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Compass Research

Orlando, Florida, United States

AvivoClin Clinical Services

Port Orange, Florida, United States

Lovelace Scientific Resources, Inc.

Sarasota, Florida, United States

Clinical Research of Tampa Bay, Inc.

Spring Hill, Florida, United States

Stedman Clinical Trials, LLC

Tampa, Florida, United States

Center for Prospective Outcome Studies, Inc.

Atlanta, Georgia, United States

North Georgia Premier Research

Dawnsonville, Georgia, United States

Taylor Research, LLC

Marietta, Georgia, United States

DrugStudies America

Marietta, Georgia, United States

Tristate Arthritis & Rheumatology Center, LLC

Evansville, Indiana, United States

Rehabilitation Associates of Indiana

Indianapolis, Indiana, United States

Integrated Clinical Trial Services, Inc.

West Des Moines, Iowa, United States

International Clinical Research Institute, Inc.

Overland Park, Kansas, United States

Kansas City Bone & Joint Clinic, Inc.

Overland Park, Kansas, United States

Willis-Knighton Pain Management Center

Shreveport, Louisiana, United States

The Rehabilitation Team West

Baltimore, Maryland, United States

Mid Atlantic Pain Medicine Center

Pikesville, Maryland, United States

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, United States

Metropolitan Hospital Center

New York, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

PharmQuest

Greensboro, North Carolina, United States

Peters Medical Research

High Point, North Carolina, United States

Raleigh Neurology Associate

Raleigh, North Carolina, United States

Columbus Clinical Research

Columbus, Ohio, United States

Allegheny Pain Management

Altoona, Pennsylvania, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Greenville Pharmaceutical

Greenville, South Carolina, United States

Comprehensive Pain Specialists, PLLC

Hendersonville, Tennessee, United States

Consultants in Pain Research

San Antonio, Texas, United States

InVisions Consultants, LLC

San Antonio, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

The Center for Pain Relief

Charleston, West Virginia, United States

Countries

United States

Other Identifiers

C25608/3055/BP/MN

Identifier Type: -

Identifier Source: org_study_id