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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


Phase 3
18 Years
80 Years
Not Enrolling
Both
Pain, Chronic Pain, Breakthrough Pain

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Day 0 (baseline), approximately week 5

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

C25608/3054/BP/US

NCT ID:

NCT00387010

Start Date:

December 2006

Completion Date:

October 2007

Related Keywords:

  • Pain
  • Chronic Pain
  • Breakthrough Pain

Name

Location

Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Pain Consultants of OregonEugene, Oregon  97401
Altoona Center for Clinical ResearchDuncansville, Pennsylvania  16635
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Lifetree Clinical ResearchSalt Lake City, Utah  84106
Allegheny Pain Management, PCAltoona, Pennsylvania  16601
Arizona Research CenterPhoenix, Arizona  85023
Clinical Research Center of NevadaLas Vegas, Nevada  89104
Birmingham Pain CenterBirmingham, Alabama  35244
Orange County Clinical TrialsAnaheim, California  92801
Vertex Clinical ResearchBakersfield, California  93311
Lovelace Scientific Resources, Inc.Beverly Hills, California  90211
Synergy Clinical Research CenterNational City, California  91950
Pain Institute of Santa MonicaSanta Monica, California  90404
Integrative Pain Manage CentersWestminster, Colorado  80021
Advanced Diagnostic Pain Treatment CenterNew Haven, Connecticut  06511
Alliance Medical Research GroupClearwater, Florida  33761
Innovative Research of West FloridaLargo, Florida  33770
Lovelace Scientific Resources, Inc.Sarasota, Florida  34233
Stedman Clinical TrialsTampa, Florida  33647
Dawsonville Family MedicineDawsonville, Georgia  30534
Millennium Pain CenterBloomington, Illinois  61701
Pain and Rehabilitation Clinic of ChicagoChicago, Illinois  60610
Rehabilitation Associates of IndianaIndianapolis, Indiana  46250
Northwest Indiana Center for Clinical Research, PCValparaiso, Indiana  46383
ICRI, Inc.Overland Park, Kansas  66211
Willis-Knighton Pain Management CenterShreveport, Louisiana  71103
Lovelace Scientific Resources CenterHenderson, Nevada  89014
SUNY - StonybrookStony Brook, New York  11794
DeGarmo Institute of Medical ResearchGreer, South Carolina  29651
Comprehensive Pain Specialists, PLLCHendersonville, Tennessee  37075
KRK Medical ResearchRichardson, Texas  75080
BeXar Clinical Trials, LLCRichardson, Texas  75082