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

NCT00387010 | Terminated Phase 3 Results

• 1 other identifier: C25608/3054/BP/US
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 33

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.

Conditions

Pain; Chronic Pain; Breakthrough Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Total Score at Approximately Week 5

  The change from baseline to approximately week 5 in the PASS total score. PASS asks participants to indicate how often they engage in each of the 40 thoughts or activities that represent anxiety symptoms on a scale of 0=never to 5=always. The total score has a range of 0-200.

  Day 0 (baseline), approximately week 5

Secondary Outcomes (17)

• Change From Baseline in the Pain Anxiety Symptoms Scale (PASS) Subscale Scores at Approximately Week 5

  Day 0 (baseline), approximately week 5

• Change From Baseline in the Beck Depression Inventory at Approximately Week 5

  Day 0 (baseline), approximately week 5

• Change From Baseline in the West Haven-Yale Multidimensional Pain Inventory Subscales at Approximately Week 5

  Day 0 (baseline), approximately week 5

• Medication Preference From the Pain Flare Treatment Satisfaction Questionnaire at Approximately Week 5

  approximately week 5

• Patient Assessment of Ability to Go to Work at Approximately Week 5

  approximately week 5

Study Arms (1)

fentanyl buccal tablets

EXPERIMENTAL

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.

Drug: Fentanyl Buccal Tablets

Interventions

Fentanyl Buccal Tablets DRUG

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.

Also known as: Fentora, CEP-25608, Fentanyl citrate

fentanyl buccal tablets

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Cephalon: lead

Study Sites (33)

Birmingham Pain Center

Birmingham, Alabama, 35244, United States

Location

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Orange County Clinical Trials

Anaheim, California, 92801, United States

Location

Vertex Clinical Research

Bakersfield, California, 93311, United States

Location

Lovelace Scientific Resources, Inc.

Beverly Hills, California, 90211, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Pain Institute of Santa Monica

Santa Monica, California, 90404, United States

Location

Integrative Pain Manage Centers

Westminster, Colorado, 80021, United States

Location

Advanced Diagnostic Pain Treatment Center

New Haven, Connecticut, 06511, United States

Location

Alliance Medical Research Group

Clearwater, Florida, 33761, United States

Location

Innovative Research of West Florida

Largo, Florida, 33770, United States

Location

Lovelace Scientific Resources, Inc.

Sarasota, Florida, 34233, United States

Location

Stedman Clinical Trials

Tampa, Florida, 33647, United States

Location

Dawsonville Family Medicine

Dawsonville, Georgia, 30534, United States

Location

Millennium Pain Center

Bloomington, Illinois, 61701, United States

Location

Pain and Rehabilitation Clinic of Chicago

Chicago, Illinois, 60610, United States

Location

Elkhart Clinic, LLC

Elkhart, Indiana, 46514, United States

Location

Rehabilitation Associates of Indiana

Indianapolis, Indiana, 46250, United States

Location

Northwest Indiana Center for Clinical Research, PC

Valparaiso, Indiana, 46383, United States

Location

ICRI, Inc.

Overland Park, Kansas, 66211, United States

Location

Willis-Knighton Pain Management Center

Shreveport, Louisiana, 71103, United States

Location

Montana Cancer Specialists

Missoula, Montana, 59802, United States

Location

Lovelace Scientific Resources Center

Henderson, Nevada, 89014, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

SUNY - Stonybrook

Stony Brook, New York, 11794, United States

Location

Pain Consultants of Oregon

Eugene, Oregon, 97401, United States

Location

Allegheny Pain Management, PC

Altoona, Pennsylvania, 16602, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

DeGarmo Institute of Medical Research

Greer, South Carolina, 29651, United States

Location

Comprehensive Pain Specialists, PLLC

Hendersonville, Tennessee, 37075, United States

Location

KRK Medical Research

Richardson, Texas, 75080, United States

Location

BeXar Clinical Trials, LLC

Richardson, Texas, 75082, United States

Location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Related Publications (1)

• 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.

  PMID: 21957829 RESULT

MeSH Terms

Conditions

Pain; Chronic Pain; Breakthrough Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This study was terminated early. Additional research is recommended to develop a valid measure of anxiety, specifically related to breakthrough pain.

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 12, 2006
• Study Start: December 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: October 22, 2012
• Results First Posted: October 22, 2012

Record last verified: 2012-09

Locations

US (33)