search
Back to results

Fentanyl Matrix in Lung Cancer Pain

Primary Purpose

Lung Cancer, Pain

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
fentanyl matrix
Sponsored by
Janssen Korea, Ltd., Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring fentanyl matrix

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with histologically confirmed lung cancer, who complain of cancer pain
  • Patients who are taking Ultracet, Tramadol, or Codeine (or Codeine combination drug) for cancer pain-relief purposes, but still complain of a pain level of 4 or above on the Numeric Rating Scale (NRS) during the past 24 hours: Ultracet 3 tablets/day, Tramadol 150 mg/day, Codeine 200 mg /day, or Codeine combination less than 3 capsules/day
  • Patients who are able to communicate with the investigator about his/her pain
  • Patients who use proper contraceptives during the study period if they are women of childbearing potential
  • Patients whose life expectancy is 3 months or longer
  • Patients who have signed an informed consent form

Exclusion Criteria:

  • Patients participating in other clinical trials
  • Patients with a history of hypersensitivity to opioid analgesics
  • Patients with a history of drug abuse
  • Patients who are unable to use a transdermal product due to skin disease
  • Patient with a history of CO2 retention (e.g. chronic obstructive pulmonary disease)
  • Patients who are receiving radiotherapy or chemotherapy when registering for the study or who plan to receive it during the study
  • Patient who are pregnant or are of childbearing potential and not using contraceptives

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    001

    Arm Description

    fentanyl matrix Fentanyl transdermal patch 12 - 25mcg/hr can increase with 12 - 25mcg/h based on pain assessment

    Outcomes

    Primary Outcome Measures

    Patient's satisfaction with pain treatment as measured by 5-point verbal scale

    Secondary Outcome Measures

    Difference in pain intensity measured by Numeric Rating Scale before and after treatment of the study drug measured
    Detailed reasons for patient's satisfaction with the pain treatment
    Patient's and investigator's satisfaction measured by 5-point verbal scale with the study drug
    Dose of fentanyl matrix

    Full Information

    First Posted
    January 29, 2010
    Last Updated
    February 4, 2010
    Sponsor
    Janssen Korea, Ltd., Korea
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01060137
    Brief Title
    Fentanyl Matrix in Lung Cancer Pain
    Official Title
    Evaluation of the Usefulness of DurogesicD-TRANS for Pain Treatment in Lung Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen Korea, Ltd., Korea

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the usefulness of fentanyl matrix by assessing patients' satisfaction when administrating fentanyl matrix, a background pain treatment, and a breakthrough pain treatment to lung cancer patients who complain of pain. Fentanyl matrix is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours).
    Detailed Description
    This study is open-label, single-arm, multicenter, prospective study to evaluate the usefulness of fentanyl matrix (fentanyl transdermal patch-type system) by assessing patient satisfaction when administrating fentanyl matrix (a background pain treatment, and a breakthrough pain treatment) for patients with lung cancer for 21 days. Fentanyl transdermal patch-type system is designed to deliver medication at a nearly constant amount per unit time into the body through the skin for 3 days (72 hours). Studies about transdermal fentanyl have found that it had analgesic effects on malignant pain, and most patients receiving the medication preferred fentanyl because they experienced less constipation. Safety assessments will include adverse event monitoring, vital signs, laboratory work. starting with 12.5g/h or 25g/h of fentanyl matrix transdermally at the investigator's discretion and flexible dose depending the patient's pain relief for 3 weeks

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer, Pain
    Keywords
    fentanyl matrix

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    268 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    001
    Arm Type
    Experimental
    Arm Description
    fentanyl matrix Fentanyl transdermal patch 12 - 25mcg/hr can increase with 12 - 25mcg/h based on pain assessment
    Intervention Type
    Drug
    Intervention Name(s)
    fentanyl matrix
    Intervention Description
    Fentanyl transdermal patch 12 - 25mcg/hr
    Primary Outcome Measure Information:
    Title
    Patient's satisfaction with pain treatment as measured by 5-point verbal scale
    Time Frame
    Day 1, 8 and 22
    Secondary Outcome Measure Information:
    Title
    Difference in pain intensity measured by Numeric Rating Scale before and after treatment of the study drug measured
    Time Frame
    Day 1 (visit 1) and 22 (visit 3)
    Title
    Detailed reasons for patient's satisfaction with the pain treatment
    Time Frame
    Day 22 (visit 3)
    Title
    Patient's and investigator's satisfaction measured by 5-point verbal scale with the study drug
    Time Frame
    Day 22 (visit 3)
    Title
    Dose of fentanyl matrix
    Time Frame
    Day 1 (visit 1), 8 (visit 2) and 22 (visit 3)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with histologically confirmed lung cancer, who complain of cancer pain Patients who are taking Ultracet, Tramadol, or Codeine (or Codeine combination drug) for cancer pain-relief purposes, but still complain of a pain level of 4 or above on the Numeric Rating Scale (NRS) during the past 24 hours: Ultracet 3 tablets/day, Tramadol 150 mg/day, Codeine 200 mg /day, or Codeine combination less than 3 capsules/day Patients who are able to communicate with the investigator about his/her pain Patients who use proper contraceptives during the study period if they are women of childbearing potential Patients whose life expectancy is 3 months or longer Patients who have signed an informed consent form Exclusion Criteria: Patients participating in other clinical trials Patients with a history of hypersensitivity to opioid analgesics Patients with a history of drug abuse Patients who are unable to use a transdermal product due to skin disease Patient with a history of CO2 retention (e.g. chronic obstructive pulmonary disease) Patients who are receiving radiotherapy or chemotherapy when registering for the study or who plan to receive it during the study Patient who are pregnant or are of childbearing potential and not using contraceptives
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Korea, Ltd. Clinical Trial
    Organizational Affiliation
    Janssen Korea, Ltd.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Fentanyl Matrix in Lung Cancer Pain

    We'll reach out to this number within 24 hrs