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Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain | Clinical Trials | Clareo Health

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

A Double Blind, Active Controlled Crossover Study to Evaluate the Efficacy and Safety of Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for the Management of Breakthrough Pain in Opioid Tolerant Patients With Chronic Pain

NCT00813488•Cephalon

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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.
+9 more criteria

Locations (50)

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

Key Dates

Start Date

December 1, 2008

Primary Completion Date

November 1, 2009

Completion Date

January 1, 2010

Last Updated

May 28, 2012

Enrollment

213

ACTUAL participants

Conditions

Chronic Pain

Interventions

Fentanyl Buccal Tablet

DRUG

Immediate release oxycodone

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

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