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Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain
This study has been completed.
First Received: February 8, 2007   Last Updated: February 27, 2009   History of Changes
Sponsor: Cephalon
Information provided by: Cephalon
ClinicalTrials.gov Identifier: NCT00463047
  Purpose

Evaluate the efficacy of treatment with Fentanyl Buccal Tablets (FBT) compared with immediate release oxycodone in alleviating breakthrough pain in opioid tolerant patients with chronic pain.


Condition Intervention Phase
Chronic Pain
Drug: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment
Official Title: A Randomized, Double-Blind, Active-Controlled Crossover Study to Evaluate the Efficacy and Safety of Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone for the Management of Breakthrough Pain in Opioid-Tolerant Patient With Chronic Pain

Resource links provided by NLM:


Further study details as provided by Cephalon:

Primary Outcome Measures:
  • To evaluate the efficacy of FBT compared with immediate-release oxycodone in alleviating BTP in patients with chronic pain as assessed by the pain intensity (PI) difference (PID) 15 minutes after the administration of study drug. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of FBT treatment compared with immediate-release oxycodone [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 324
Study Start Date: June 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
This study includes a screening period, 2 open-label dose titration periods (in randomized order), and 2 double-blind treatment periods (in randomized order).
Drug: Fentanyl Buccal Tablets Compared With Immediate-Release Oxycodone
Patients will be randomly assigned in a 1:1 ratio either to titrate immediate-release oxycodone first and to titrate FBT second, or to titrate FBT first and immediate-release oxycodone second.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has chronic pain of at least 3 months duration associated with: diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain,fibromyalgia, chronic pancreatitis, osteoarthritis,or cancer.
  • 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 ATC therapy for at least 7 days before administration of the first dose of study drug
  • 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 and agree to continued use of this method for the duration of the study.
  • Any patient with cancer should have a life expectancy of at least 3 months.
  • The patient reports an average PI score, over the prior 24 hours, of 6 or less (0=no pain through 10=pain as bad as you can imagine) for their 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 4 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, complete the electronic diary, and return to the clinic for scheduled study visits 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 a recent history (within 5 years) or current evidence of alcohol or other substance abuse.
  • The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in either study drug.
  • The patient has cardiopulmonary disease that would, in the opinion of the investigator, 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 is expected to have surgery during the study that will impact the patient's chronic pain and/or BTP.
  • 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 FBT.
  • The patient has participated in a study involving an investigational drug in the prior 30 days.
  • The patient is currently using prescription FBT or immediate-release oxycodone for BTP and is unwilling to undergo re-titration.
  • 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 could, in the opinion of the investigator, 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 the chronic pain currently being treated.
  • The patient has a positive UDS for an illicit drug or a medication not prescribed for him/her or which is not medically explainable.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463047

  Show 45 Study Locations
Sponsors and Collaborators
Cephalon
  More Information

No publications provided

Responsible Party: Cephalon ( Sponsor's Medical Expert )
Study ID Numbers: C25608/3055/BP/MN
Study First Received: February 8, 2007
Last Updated: February 27, 2009
ClinicalTrials.gov Identifier: NCT00463047     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Cephalon:
Breakthrough pain
Opioid-tolerant
Chronic pain

Additional relevant MeSH terms:
Anesthetics, Intravenous
Fentanyl
Nervous System Diseases
Oxycodone
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Pain
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia
Signs and Symptoms
Anesthetics, General
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010