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Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain

A 4-week Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Pain

NCT00387010•Cephalon

View on ClinicalTrials.gov

Summary

The primary purpose of the study is to evaluate the impact of treatment with fentanyl buccal tablets on the anxiety symptoms commonly associated with chronic pain in patients with breakthrough pain (BTP). Other purposes are to assess the management of BTP, to evaluate patient functioning, and to determine any influences on the successful dose achieved.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 (i.e., barrier method with spermicide, steroidal contraceptive \[oral, transdermal, implanted, and injected contraceptives must be used in conjunction with the barrier method\], 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: cancer, diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia (patient has met diagnostic criteria), chronic pancreatitis, or osteoarthritis. Other chronic painful conditions may be evaluated for entry upon discussion with and written approval from the Cephalon medical expert.
•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 around-the-clock (ATC) therapy for at least 7 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 the chronic pain.
•The patient experiences, on average, 1 to 4 BTP episodes per day while taking around-the-clock (ATC) opioid therapy, and on average, the duration of each breakthrough pain (BTP) episode is less than 3 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, and return to the clinic for scheduled study visits and a follow-up evaluation as specified in this protocol.

Exclusion Criteria

•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, in the opinion of the investigator, would 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's primary painful condition is headache, including migraine.
•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 fentanyl buccal tablets.
+5 more criteria

Locations (33)

Birmingham Pain Center

Birmingham, Alabama, United States

Arizona Research Center

Phoenix, Arizona, United States

Orange County Clinical Trials

Anaheim, California, United States

Vertex Clinical Research

Bakersfield, California, United States

Lovelace Scientific Resources, Inc.

Beverly Hills, California, United States

Synergy Clinical Research Center

National City, California, United States

Pain Institute of Santa Monica

Santa Monica, California, United States

Integrative Pain Manage Centers

Westminster, Colorado, United States

Advanced Diagnostic Pain Treatment Center

New Haven, Connecticut, United States

Alliance Medical Research Group

Clearwater, Florida, United States

Key Dates

Start Date

December 1, 2006

Primary Completion Date

October 1, 2007

Completion Date

October 1, 2007

Last Updated

October 22, 2012

Enrollment

218

ACTUAL participants

Conditions

PainChronic PainBreakthrough Pain

Interventions

Fentanyl Buccal Tablets

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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: October 22, 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

Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough Pain

Inclusion Criteria

Exclusion Criteria

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