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
Information source: Cephalon
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Fentanyl Buccal Tablets (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Cephalon
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.
Clinical Details
Official title: 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
Study design: Treatment, Open Label, Placebo Control, Single Group Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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 (ie, 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 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 ATC
opioid therapy, and on average, the duration of each BTP episode is less than 3
hours.
- The patient currently uses opioid therapy for alleviation of BTP episodes occuring 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.
- 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 (eg, 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.
Locations and Contacts
Birmingham Pain Center, Birmingham, Alabama 35244, United States
Arizona Research Center, Phoenix, Arizona 85023, United States
Lovelace Scientific Resources, Inc., Beverly Hills, California 90211, United States
Vertex Clinical Research, Bakersfield, California 93311, United States
Orange County Clinical Trials, Anaheim, California 92801, United States
Synergy Clinical Research Center, National City, California 91950, United States
Pain Institute of Santa Monica, Santa Monica, California 90404, United States
Integrative Pain Manage Centers, Westminster, Colorado 80021, United States
Advanced Diagnostic Pain Treatment Center, New Haven, Connecticut 06511, United States
Lovelace Scientific Resources, Inc., Sarasota, Florida 34233, United States
Alliance Medical Research Group, Clearwater, Florida 33761, United States
Innovative Research of West Florida, Largo, Florida 33770, United States
Stedman Clinical Trials, Tampa, Florida 33647, United States
Dawsonville Family Medicine, Dawsonville, Georgia 30534, United States
Millennium Pain Center, Bloomington, Illinois 61701, United States
Pain and Rehabilitation Clinic of Chicago, Chicago, Illinois 60610, United States
Northwest Indiana Center for Clinical Research, PC, Valparaiso, Indiana 46383, United States
Rehabilitation Associates of Indiana, Indianapolis, Indiana 46250, United States
Elkhart Clinic, LLC, Elkhart, Indiana 46514, United States
ICRI, Inc., Overland Park, Kansas 66211, United States
Willis-Knighton Pain Management Center, Shreveport, Louisiana 71103, United States
Montana Cancer Specialists, Missoula, Montana 59802, United States
Lovelace Scientific Resources Center, Henderson, Nevada 89014, United States
Clinical Research Center of Nevada, Las Vegas, Nevada 89104, United States
SUNY - Stonybrook, Stony Brook, New York 11794, United States
Pain Consultants of Oregon, Eugene, Oregon 97401, United States
Allegheny Pain Management, PC, Altoona, Pennsylvania 16602, United States
Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States
DeGarmo Institute of Medical Research, Greer, South Carolina 29651, United States
Comprehensive Pain Specialists, PLLC, Hendersonville, Tennessee 37075, United States
KRK Medical Research, Richardson, Texas 75080, United States
BeXar Clinical Trials, LLC, Richardson, Texas 75082, United States
Lifetree Clinical Research, Salt Lake City, Utah 84106, United States
Additional Information
Starting date: November 2006
Ending date: October 2007
Last updated: November 9, 2007
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