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Phase II Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Cancer Pain- Assessment of Effectiveness, Safety and Pharmacokinetics -

Primary Purpose

Pain, Intractable

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
fentanyl
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Intractable focused on measuring Fentanyl, Cancer pain, Japanese patients

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with cancer pain receiving any of the following treatments constantly for at least 3days before the treatment period :(1)Morphine preparations equivalent to less than 45 mg/day of oral morphine (or less than 30 mg/day of suppositories, or less than 15 mg/day of injectable preparations), (2)oral oxycodone preparations equivalent to less than 30 mg/day, (3)Fentanyl citrate injectable solution equivalent to less than 0.3 mg/day Patients with a pain intensity of less than or equal to 34 mm on the 100 mm Visual Analogue Scale (VAS) Patients with an established diagnosis of cancer of any type who have been notified of the disease Patients may be hospitalized during application of the initial transdermal dose of fentanyl transdermal matrix patch (patients may be ambulatory after the initial patch has been replaced with the second dose) Exclusion Criteria: Patients with respiratory dysfunction such as chronic pulmonary disease Patients with asthma Patients with bradyarrhythmia Patients with concurrent liver and/or kidney dysfunction according to the latest laboratory test values within 14 days before the start of the pre-treatment observation period Patients with organic brain disorder such as elevated intracranial pressure, disturbance of consciousness/coma, or brain tumor Patients with any psychoneurologic complication and judged incapable of self assessment Patients with a history of drug dependency or narcotic abuse Patients with a history of hypersensitivity to fentanyl or any other opioid analgesic

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Patient's global assessments of pain

    Secondary Outcome Measures

    Physician's global assessments, pain intensity (Visual Analog Scale: VAS), pain intensity (categorical scale), total pain duration per day, and dose of rescue medication, Adverse events, laboratory values, and vital signs. Pharmacokinetics

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    January 20, 2011
    Sponsor
    Janssen Pharmaceutical K.K.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00216658
    Brief Title
    Phase II Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Cancer Pain- Assessment of Effectiveness, Safety and Pharmacokinetics -
    Official Title
    Open Label Study to Confirm Effectiveness, Safety and Pharmacokinetics of Fentanyl Transdermal Matrix Patch, in Japanese Patients With Cancer Pain Who Have Had a Minimum Amount of Morphine Therapy, Such as Equal to Less Than 45 mg/Day of Oral Morphine or Oxycodone Equal to Less Than 30 mg/Day.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen Pharmaceutical K.K.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to verify the effectiveness, safety and pharmacokinetics of fentanyl transdermal matrix patches containing either 12.5 mcg/hr, 25 mcg/hr, or 50 mcg/hr in Japanese patients with cancer pain who have been switched from minimum amount of existing morphine preparations, such as equivalent to less than 45 mg/day of oral morphine, or oral oxycodone preparations equivalent to less than 30 mg/day.
    Detailed Description
    Fentanyl transdermal matrix patch is a narcotic analgesic agent. Compared with the existing reservoir-type Durotep® Patch, it is not liable to leakage of drug solution and does not contain alcohol, which becomes a cause of skin irritation. Also this new formulation becomes available of smaller one of 12.5 mcg/hr while the smallest Durotep® Patch is 25 mcg/hr. This clinical trial was planned to assess effectiveness, safety and pharmacokinetics of fentanyl transdermal matrix patch at an initial transdermal dose of 12.5 mcg in Japanese cancer patients with pain receiving morphine preparations equivalent to less than 45 mg/day of oral morphine (less than 30 mg for suppository, less than 15 mg for injection), oral oxycodone preparations equivalent to less than 30 mg/day, or fentanyl citrate injectable solution equivalent to less than 0.3 mg/day. After pre-treatment period for one to three days for evaluating the eligibility of the patients for the study, patients will use 3 patches for 10 days. Starting from the first day of treatment with 12.5 mcg/hr patch, fentanyl will be applied to the chest, the upper arm or other appropriate site, which will be replaced with a new patch every three days (ca. 72 hr). Total treatment duration is ten days, and dose adjustment can be allowed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Intractable
    Keywords
    Fentanyl, Cancer pain, Japanese patients

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    87 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    fentanyl
    Primary Outcome Measure Information:
    Title
    Patient's global assessments of pain
    Secondary Outcome Measure Information:
    Title
    Physician's global assessments, pain intensity (Visual Analog Scale: VAS), pain intensity (categorical scale), total pain duration per day, and dose of rescue medication, Adverse events, laboratory values, and vital signs. Pharmacokinetics

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with cancer pain receiving any of the following treatments constantly for at least 3days before the treatment period :(1)Morphine preparations equivalent to less than 45 mg/day of oral morphine (or less than 30 mg/day of suppositories, or less than 15 mg/day of injectable preparations), (2)oral oxycodone preparations equivalent to less than 30 mg/day, (3)Fentanyl citrate injectable solution equivalent to less than 0.3 mg/day Patients with a pain intensity of less than or equal to 34 mm on the 100 mm Visual Analogue Scale (VAS) Patients with an established diagnosis of cancer of any type who have been notified of the disease Patients may be hospitalized during application of the initial transdermal dose of fentanyl transdermal matrix patch (patients may be ambulatory after the initial patch has been replaced with the second dose) Exclusion Criteria: Patients with respiratory dysfunction such as chronic pulmonary disease Patients with asthma Patients with bradyarrhythmia Patients with concurrent liver and/or kidney dysfunction according to the latest laboratory test values within 14 days before the start of the pre-treatment observation period Patients with organic brain disorder such as elevated intracranial pressure, disturbance of consciousness/coma, or brain tumor Patients with any psychoneurologic complication and judged incapable of self assessment Patients with a history of drug dependency or narcotic abuse Patients with a history of hypersensitivity to fentanyl or any other opioid analgesic
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Pharmaceutical K.K. Clinical Trial
    Organizational Affiliation
    Janssen Pharmaceutical K.K.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Phase II Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Cancer Pain- Assessment of Effectiveness, Safety and Pharmacokinetics -

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