Clinical trial NCT00387010: 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
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain
Chronic Pain
Breakthrough Pain
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-12
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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 (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.
* 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.

Primary outcomes:
measure: Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Total Score at Approximately Week 5
timeFrame: Day 0 (baseline), approximately week 5
Secondary outcomes:
measure: Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Subscale Scores at Approximately Week 5
timeFrame: Day 0 (baseline), approximately week 5
measure: Change From Baseline in the Beck Depression Inventory at Approximately Week 5
timeFrame: Day 0 (baseline), approximately week 5
measure: Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5
timeFrame: Day 0 (baseline), approximately week 5
measure: Medication Preference From the Pain Flare Treatment Satisfaction Questionnaire at Approximately Week 5
timeFrame: approximately week 5
measure: Patient Assessment of Ability to Go to Work at Approximately Week 5
timeFrame: approximately week 5
measure: Patient Assessment of Ability to Perform at Work at Approximately Week 5
timeFrame: approximately week 5
measure: Patient Assessment of Ability to Walk at Approximately Week 5
timeFrame: approximately week 5
measure: Patient Assessment of Ability to Exercise at Approximately Week 5
timeFrame: approximately week 5
measure: Patient Assessment of Ability to Participate in Social Events at Approximately Week 5
timeFrame: approximately week 5
measure: Patient Assessment of Ability to Have Sex at Approximately Week 5
timeFrame: approximately week 5
measure: Patient Assessment of Ability to Enjoy Life at Approximately Week 5
timeFrame: approximately week 5
measure: Clinical Assessment of Patient Function - General Activities - at Approximately Week 5
timeFrame: approximately week 5
measure: Clinical Assessment of Patient Function - Patient's Walking Ability - at Approximately Week 5
timeFrame: approximately week 5
measure: Clinical Assessment of Patient Function - Patient's Ability to Work/Perform Activities of Daily Living - at Approximately Week 5
timeFrame: approximately week 5
measure: Clinical Assessment of Patient Function - Patient's Relationship With Others - at Approximately Week 5
timeFrame: approximately week 5
measure: Clinical Assessment of Patient Function - Patient's Enjoyment of Life - at Approximately Week 5
timeFrame: approximately week 5
measure: Summary of Participants' Successful Dosing Levels of Fentanyl Buccal Tablets to Control Episodes of Breakthrough Pain (BTP)
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pain Center
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Anaheim
country: United States
facility: Orange County Clinical Trials
state: California
city: Bakersfield
country: United States
facility: Vertex Clinical Research
state: California
city: Beverly Hills
country: United States
facility: Lovelace Scientific Resources, Inc.
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Santa Monica
country: United States
facility: Pain Institute of Santa Monica
state: California
city: Westminster
country: United States
facility: Integrative Pain Manage Centers
state: Colorado
city: New Haven
country: United States
facility: Advanced Diagnostic Pain Treatment Center
state: Connecticut
city: Clearwater
country: United States
facility: Alliance Medical Research Group
state: Florida
city: Largo
country: United States
facility: Innovative Research of West Florida
state: Florida
city: Sarasota
country: United States
facility: Lovelace Scientific Resources, Inc.
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Dawsonville
country: United States
facility: Dawsonville Family Medicine
state: Georgia
city: Bloomington
country: United States
facility: Millennium Pain Center
state: Illinois
city: Chicago
country: United States
facility: Pain and Rehabilitation Clinic of Chicago
state: Illinois
city: Elkhart
country: United States
facility: Elkhart Clinic, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Rehabilitation Associates of Indiana
state: Indiana
city: Valparaiso
country: United States
facility: Northwest Indiana Center for Clinical Research, PC
state: Indiana
city: Overland Park
country: United States
facility: ICRI, Inc.
state: Kansas
city: Shreveport
country: United States
facility: Willis-Knighton Pain Management Center
state: Louisiana
city: Missoula
country: United States
facility: Montana Cancer Specialists
state: Montana
city: Henderson
country: United States
facility: Lovelace Scientific Resources Center
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Center of Nevada
state: Nevada
city: Stony Brook
country: United States
facility: SUNY - Stonybrook
state: New York
city: Eugene
country: United States
facility: Pain Consultants of Oregon
state: Oregon
city: Altoona
country: United States
facility: Allegheny Pain Management, PC
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Greer
country: United States
facility: DeGarmo Institute of Medical Research
state: South Carolina
city: Hendersonville
country: United States
facility: Comprehensive Pain Specialists, PLLC
state: Tennessee
city: Richardson
country: United States
facility: KRK Medical Research
state: Texas
city: Richardson
country: United States
facility: BeXar Clinical Trials, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
Study officials:
References:
citation: 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.