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Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)

Primary Purpose

Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Fentanyl (Matrifen)
Sponsored by
Nycomed
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects that have insufficiently treated, cancer-related chronic pain that requires long-term treatment with an opioid at Step 3 on the WHO Ladder, and with Karnofsky performance status above 50. Subject informed consent given. Aged between 18 and 75 years, and for female subjects a proven negative pregnancy test and adequate contraception. No significant skin lesions on relevant surfaces on the body or diffuse skin diseases. No impaired respiratory function nor neurological or psychiatric impairment. No known abuse of drug, narcotic or alcohol. Not pregnant or nursing. Not hypersensitive/allergic to fentanyl or morphine. No head injury, primary brain tumor, increased intracranial pressure or impaired consciousness. Not participating in other clinical trials. Exclusion Criteria: All exclusion criteria must be answered No for a patient to participate in the trial. Does the patient have significant skin lesions on the upper arms/flat surface of the upper torso or diffuse skin disease (psoriasis or eczema) that preclude application of fentanyl patches? Does the patient have a known abuse of drug, narcotic or alcohol? Is the patient pregnant or nursing? Has the patient neurological or mental impairment that may compromise data collection? Is the patient hypersensitive/allergic to fentanyl or morphine or any of the ingredients in the trial medication? Has the patient any major head injury, primary brain tumour, increased intracranial pressure or impaired consciousness? Does the patient participate in other clinical with other investigational drugs or investigation al medical devices or has been participating in such a trial for the past 30 days?

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Primary:
    To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment and to assess the safety of FITpatch compared to standard opioid treatment

    Secondary Outcome Measures

    Secondary:
    To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment and to assess Quality of life reported with FITpatch compared to standard opioid treatment

    Full Information

    First Posted
    December 14, 2005
    Last Updated
    May 4, 2012
    Sponsor
    Nycomed
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00279344
    Brief Title
    Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)
    Official Title
    A Randomised, Open, Parallel-group, Multi-centre Trial to Investigate Analgesic Efficacy and Safety of Transdermal Fentanyl (FITpatch) Compared to Standard Opioid Treatment in Cancer Pain.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Nycomed

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Primary objectives: To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment To assess the safety of FITpatch compared to standard opioid treatment Secondary objectives: To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment To assess Quality of life reported with FITpatch compared to standard opioid treatment

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Standard Opioid Analgesic Treatment of Cancer-related Chronic Pain.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    220 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl (Matrifen)
    Primary Outcome Measure Information:
    Title
    Primary:
    Title
    To determine non-inferiority of FITpatch with regard to efficacy compared to standard opioid treatment and to assess the safety of FITpatch compared to standard opioid treatment
    Secondary Outcome Measure Information:
    Title
    Secondary:
    Title
    To assess the intake of oral morphine as rescue analgesic to FITpatch compared to standard opioid treatment and to assess Quality of life reported with FITpatch compared to standard opioid treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects that have insufficiently treated, cancer-related chronic pain that requires long-term treatment with an opioid at Step 3 on the WHO Ladder, and with Karnofsky performance status above 50. Subject informed consent given. Aged between 18 and 75 years, and for female subjects a proven negative pregnancy test and adequate contraception. No significant skin lesions on relevant surfaces on the body or diffuse skin diseases. No impaired respiratory function nor neurological or psychiatric impairment. No known abuse of drug, narcotic or alcohol. Not pregnant or nursing. Not hypersensitive/allergic to fentanyl or morphine. No head injury, primary brain tumor, increased intracranial pressure or impaired consciousness. Not participating in other clinical trials. Exclusion Criteria: All exclusion criteria must be answered No for a patient to participate in the trial. Does the patient have significant skin lesions on the upper arms/flat surface of the upper torso or diffuse skin disease (psoriasis or eczema) that preclude application of fentanyl patches? Does the patient have a known abuse of drug, narcotic or alcohol? Is the patient pregnant or nursing? Has the patient neurological or mental impairment that may compromise data collection? Is the patient hypersensitive/allergic to fentanyl or morphine or any of the ingredients in the trial medication? Has the patient any major head injury, primary brain tumour, increased intracranial pressure or impaired consciousness? Does the patient participate in other clinical with other investigational drugs or investigation al medical devices or has been participating in such a trial for the past 30 days?
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nycomed Clinical Project Management
    Organizational Affiliation
    Headquaters
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety of FITpatch Compared to Standard Opioid Treatment in Cancer Pain (FT-015-IN)

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