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

Stopped early · Phase 3

Conditions studied: Pain, Chronic Pain, Breakthrough Pain

In brief

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.

Key facts

Study ID

NCT00387010

Run by

Cephalon

People needed

218

Starts

2006-12-01

Expected to finish

2007-10-01

Last updated by the study team

2012-10-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• 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 (e.g., regional nerve block) that, in the opinion of the investigator, would 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 chronic pain currently being treated.
• The patient has a positive urine drug screen (UDS) for an illicit substance or a medication not legitimately prescribed to the patient.

Where it is running

• 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
• Innovative Research of West Florida — Largo, Florida, United States
• Lovelace Scientific Resources, Inc. — Sarasota, Florida, United States
• Stedman Clinical Trials — Tampa, Florida, United States
• Dawsonville Family Medicine — Dawsonville, Georgia, United States
• Millennium Pain Center — Bloomington, Illinois, United States
• Pain and Rehabilitation Clinic of Chicago — Chicago, Illinois, United States
• Elkhart Clinic, LLC — Elkhart, Indiana, United States
• Rehabilitation Associates of Indiana — Indianapolis, Indiana, United States
• Northwest Indiana Center for Clinical Research, PC — Valparaiso, Indiana, United States
• ICRI, Inc. — Overland Park, Kansas, United States
• Willis-Knighton Pain Management Center — Shreveport, Louisiana, United States
• Montana Cancer Specialists — Missoula, Montana, United States
• Lovelace Scientific Resources Center — Henderson, Nevada, United States
• Clinical Research Center of Nevada — Las Vegas, Nevada, United States
• SUNY - Stonybrook — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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