Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain

NCT ID: NCT00813488

Last Updated: 2012-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-01-31

Brief Summary

Evaluate the efficacy of treatment with the fentanyl buccal tablet (FBT) compared with immediate release oxycodone treatment in alleviating breakthrough pain (BTP) in opioid tolerant patients with chronic pain.

Conditions

Chronic Pain

Study Design

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

Study Groups

Fentanyl buccal tablet first then immediate release oxycodone

This crossover study includes a screening period, two titration periods, two double-blind treatment periods during which subjects will be randomized to receive fentanyl buccal tablet (FBT) plus placebo during the first treatment period and then immediate release oxycodone plus placebo during the second treatment period or vice versa, then followed by a 12-week open-label treatment period with FBT or an alternative short acting opioid.

Group Type: EXPERIMENTAL

Fentanyl Buccal Tablet

Intervention Type: DRUG

FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain.

The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets).

For the subsequent 12-week open-label treatment period, patients will either continue with FBT treatment or begin treatment with an alternative short-acting opioid deemed appropriate for each patient by the clinician.

Immediate release oxycodone

Intervention Type: DRUG

Immediate release oxycodone dosage strength: 15, 30, 45, and 60 mg doses (1, 2, 3 or 4 capsules) to be taken prn (as needed) for breakthrough pain.

The maximum single dose would be 60 mg (4 capsules).

Immediate Release Oxycodone first then FBT

This crossover study includes a screening period, two titration periods, two double-blind treatment periods during which subjects will be randomized to receive fentanyl buccal tablet (FBT) plus placebo during the first treatment period and then immediate release oxycodone plus placebo during the second treatment period or vice versa, then followed by a 12-week open-label treatment period with FBT or an alternative short acting opioid.

Group Type: EXPERIMENTAL

Fentanyl Buccal Tablet

Intervention Type: DRUG

FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain.

The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets).

For the subsequent 12-week open-label treatment period, patients will either continue with FBT treatment or begin treatment with an alternative short-acting opioid deemed appropriate for each patient by the clinician.

Immediate release oxycodone

Intervention Type: DRUG

Immediate release oxycodone dosage strength: 15, 30, 45, and 60 mg doses (1, 2, 3 or 4 capsules) to be taken prn (as needed) for breakthrough pain.

The maximum single dose would be 60 mg (4 capsules).

Interventions

Fentanyl Buccal Tablet

FBT dose strengths = 200, 400, 600, or 800 mcg (1, 2, 3, or 4 tablets) taken prn (as needed) in the event of breakthrough pain.

The maximum dose of FBT permitted during the titration and double-blind periods in this study is 800 mcg (4 tablets).

For the subsequent 12-week open-label treatment period, patients will either continue with FBT treatment or begin treatment with an alternative short-acting opioid deemed appropriate for each patient by the clinician.

Intervention Type: DRUG

Immediate release oxycodone

Immediate release oxycodone dosage strength: 15, 30, 45, and 60 mg doses (1, 2, 3 or 4 capsules) to be taken prn (as needed) for breakthrough pain.

The maximum single dose would be 60 mg (4 capsules).

Intervention Type: DRUG

Other Intervention Names

CEP-25608

Eligibility Criteria

Inclusion Criteria

• 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, chronic pancreatitis, osteoarthritis, rheumatoid arthritis, or cancer. Other chronic painful conditions may be evaluated for possible inclusion.
• The patient is currently using at least one 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 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, including a written opioid agreement form, to participate in this study.
• 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 PI score, over the 24 hours prior to screening, 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, at least 1 and less than 5 BTP episodes per day while taking ATC opioid therapy, and on average, the duration of each BTP episode is less than 4 hours during the screening period.
• 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 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 a diagnosis of chronic headache or migraine as the primary painful condition with associated BTP.
• 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 the patient's safety or collected data.
• The patient has suicidal ideation at screening or has a history of suicidal ideation within 1 year or history of suicide attempt within 2 years before screening, or a diagnosis of bipolar disorder or history of schizophrenia
• 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 FBT or oral transmucosal fentanyl citrate for BTP.
• The patient is currently using 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 (e.g., 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 UDS for an illicit drug or a medication not prescribed for him/her or which is not medically explainable (i.e., active metabolites).
• The investigator feels that the patient is not suitable for the study for any reason (e.g., the patient's social history indicates an increased risk of drug diversion)

• 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

Principal Investigators

Sponsor's Medical Expert, MD

Role: STUDY_DIRECTOR

Cephalon

Locations

Parkway Medical Center

Birmingham, Alabama, United States

Horizon Research Group, Inc

Mobile, Alabama, United States

Robert Karns, MD a Medical Corporation

Beverly Hills, California, United States

Catalina Research Institute, LLC

Chino, California, United States

Pacific Coast Pain Management

Laguna Hills, California, United States

Loma Linda University Health

Loma Linda, California, United States

VA Northern California Health

Mather, California, United States

New England Research Associates

Trumbull, Connecticut, United States

Delray Research Associates

Delray Beach, Florida, United States

Emerald Coast Research Group Inc

Marianna, Florida, United States

Compass Research, LLC

Orlando, Florida, United States

Gold Coast Research

Plantation, Florida, United States

Sarasota Pain Medicine Research

Sarasota, Florida, United States

Suncoast Neuroscience Associates

St. Petersburg, Florida, United States

Clinical Research of West Florida

Tampa, Florida, United States

Taylor Research

Marietta, Georgia, United States

Drug Studies America

Marietta, Georgia, United States

Georgia Pain Care

Newnan, Georgia, United States

South Coast Medical Group

Savannah, Georgia, United States

Millennium Pain Center

Bloomington, Illinois, United States

Suburban Clinical Research

Bolingbrook, Illinois, United States

Knight Center for Integrated Health

Peoria, Illinois, United States

Indiana Medical Research

Elkhart, Indiana, United States

Rehabilitation Associates of Indiana

Indianapolis, Indiana, United States

Indiana Pain & Spine Clinic

South Bend, Indiana, United States

ICRI Inc.

Overland Park, Kansas, United States

The Pain Treatment Center of the Bluegrass

Lexington, Kentucky, United States

Gulf Coast Research Associates, Inc

Baton Rouge, Louisiana, United States

Columbia Medical Practice

Columbia, Maryland, United States

MidAtlantic Pain Medicine Center

Pikesville, Maryland, United States

Michigan Neurology Associates PC

Clinton Township, Michigan, United States

CRC of Jackson

Jackson, Mississippi, United States

Healthcare Research

Florissant, Missouri, United States

Clinical Research Center of Nevada

Las Vegas, Nevada, United States

Five Towns Neuroscience Research

Cedarhurst, New York, United States

Upstate Clinical Research Associates

Williamsville, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Clinical Research Source Inc

Perrysburg, Ohio, United States

Pain Research of Oregon

Eugene, Oregon, United States

Allegheny Pain Management

Altoona, Pennsylvania, United States

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, United States

CRI Worldwide

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Clinical Research Center

West Reading, Pennsylvania, United States

Greenville Pharmaceutical Research

Greenville, South Carolina, United States

Trident Institute of Medical Research, LLC

North Charleston, South Carolina, United States

South Carolina Pharmaceutical Research

Spartanburg, South Carolina, United States

Lovelace Scientific

Austin, Texas, United States

Sun Research Institute

San Antonio, Texas, United States

Aspen Clinical Research

Orem, Utah, United States

Countries

United States

References

Webster LR, Slevin KA, Narayana A, Earl CQ, Yang R. Fentanyl buccal tablet compared with immediate-release oxycodone for the management of breakthrough pain in opioid-tolerant patients with chronic cancer and noncancer pain: a randomized, double-blind, crossover study followed by a 12-week open-label phase to evaluate patient outcomes. Pain Med. 2013 Sep;14(9):1332-45. doi: 10.1111/pme.12184. Epub 2013 Jul 15.

Reference Type: DERIVED

PMID: 23855816 (View on PubMed)

Other Identifiers

C25608/3056/BP/US

Identifier Type: -

Identifier Source: org_study_id