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
NCT ID: NCT00387010
Last Updated: 2012-10-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
218 participants
INTERVENTIONAL
2006-12-31
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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fentanyl buccal tablets
Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
Fentanyl Buccal Tablets
Fentanyl buccal tablets (FBT) placed in the buccal cavity above a rear molar until disintegrated, approximately 14-25 minutes.
Dose titration: Participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg as needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated.
Open-label: Once the successful dose of FBT was identified (100, 200, 400, 600, or 800 mcg), participants were dispensed a 4-week supply at the successful dose. Participants were not to use FBT for more than 6 BTP episodes or take more than 8 FBT daily.
Interventions
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Fentanyl Buccal Tablets
Fentanyl buccal tablets (FBT) placed in the buccal cavity above a rear molar until disintegrated, approximately 14-25 minutes.
Dose titration: Participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg as needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated.
Open-label: Once the successful dose of FBT was identified (100, 200, 400, 600, or 800 mcg), participants were dispensed a 4-week supply at the successful dose. Participants were not to use FBT for more than 6 BTP episodes or take more than 8 FBT daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Responsible Party
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Locations
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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
Pain Consultants of Oregon
Eugene, Oregon, United States
Allegheny Pain Management, PC
Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
DeGarmo Institute of Medical Research
Greer, South Carolina, United States
Comprehensive Pain Specialists, PLLC
Hendersonville, Tennessee, United States
KRK Medical Research
Richardson, Texas, United States
BeXar Clinical Trials, LLC
Richardson, Texas, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
Countries
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References
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Webster LR, Messina J, Xie F, Nalamachu S. Effect of fentanyl buccal tablet on pain-related anxiety: a 4-week open-label study among opioid-tolerant patients with chronic and breakthrough pain. J Opioid Manag. 2011 Jul-Aug;7(4):297-308.
Other Identifiers
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C25608/3054/BP/US
Identifier Type: -
Identifier Source: org_study_id