search
Back to results

Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain

Primary Purpose

Pain

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
fentanyl
Sponsored by
Janssen Cilag S.A.S.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Fentanyl, Analgesia, Pain, Cancer pain, Opioid analgesia, Transdermal fentanyl, Patient-controlled analgesia

Eligibility Criteria

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

Inclusion Criteria: Less than a month of opioid treatment over the past 3 months Proven cancer and chronic stable, cancer-related pain Pain control medication (aside from opioids) at the maximum authorized dose in the 24-hours preceding the first study visit A pain score of at least 4 on the VAS scale and pain that justifies intervention by opium-derived drugs in the opinion of the investigator Exclusion Criteria: Liver or kidney problems Previous heart, lung or nervous disorders Allergy to fentanyl Skin condition that might interfere with absorption of the fentanyl through the skin Surgery or chemotherapy in the month preceding the study or scheduled during the 56 days of the study History of substance abuse

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Pain control level using a visual analog scale (VAS) at various time points and at the end of 56-day study. Percent pain reduction and percentage of patients having a score of 4 or lower compared to the baseline. Use of rescue medication.

    Secondary Outcome Measures

    Constipation and recorded use of laxatives, patient-assessed quality of life obtained by questionnaires and overall tolerance assessed at the end of 56-day study.

    Full Information

    First Posted
    October 7, 2005
    Last Updated
    May 16, 2011
    Sponsor
    Janssen Cilag S.A.S.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00236327
    Brief Title
    Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain
    Official Title
    Evaluation of the Efficacy and Safety of Transdermal Fentanyl in Patients Suffering From Chronic Cancer Pain in an Ambulatory Setting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Terminated
    Why Stopped
    Sponsor discontinued the study following the discovery of a number of incompletely sealed batches that were unusable.
    Study Start Date
    June 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen Cilag S.A.S.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the safety and efficacy of pain control by fentanyl, administered via adhesive skin patches, at doses of 25 to 100 micrograms per hour in 80 out-patients with intense chronic cancer pain. Higher doses are allowed by permission of the investigator and rescue oral morphine medication is allowed.
    Detailed Description
    Patients with cancer pain are frequently under-medicated with morphine. This is a 56-day open-label study of the efficacy and safety of self-administered fentanyl skin patches for cancer pain control in patients in the home-care setting not previously using morphine. The first 15 days of the study are for dose stabilization and the rest of the study assesses pain control and quality of life at stable doses of medication. The dose is determined by the patient with oversight by the investigator, and rescue oral morphine medication can be used when necessary. The patient records all medication use in a diary and fills out questionnaires concerning pain control, intestinal function (constipation) and overall quality of life. The hypothesis is that patients will be able to control their cancer pain by self-administering transdermal fentanyl at home and that they will well tolerate the medication. Individualized doses, with a target dose of 25 to 100 micrograms per hour of fentanyl for 56 days via skin patches applied every 3 days to deliver 25 to 100 micrograms of fentanyl per hour per patch; oral morphine as rescue medication for pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain
    Keywords
    Fentanyl, Analgesia, Pain, Cancer pain, Opioid analgesia, Transdermal fentanyl, Patient-controlled analgesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    fentanyl
    Primary Outcome Measure Information:
    Title
    Pain control level using a visual analog scale (VAS) at various time points and at the end of 56-day study. Percent pain reduction and percentage of patients having a score of 4 or lower compared to the baseline. Use of rescue medication.
    Secondary Outcome Measure Information:
    Title
    Constipation and recorded use of laxatives, patient-assessed quality of life obtained by questionnaires and overall tolerance assessed at the end of 56-day study.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Less than a month of opioid treatment over the past 3 months Proven cancer and chronic stable, cancer-related pain Pain control medication (aside from opioids) at the maximum authorized dose in the 24-hours preceding the first study visit A pain score of at least 4 on the VAS scale and pain that justifies intervention by opium-derived drugs in the opinion of the investigator Exclusion Criteria: Liver or kidney problems Previous heart, lung or nervous disorders Allergy to fentanyl Skin condition that might interfere with absorption of the fentanyl through the skin Surgery or chemotherapy in the month preceding the study or scheduled during the 56 days of the study History of substance abuse
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen-Cilag S.A.S. Clinical Trial
    Organizational Affiliation
    Janssen Cilag S.A.S.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=272&filename=CR002920_CSR.pdf
    Description
    Assessment of the efficacy and tolerance of transdermal fentanyl in patients with chronic cancer pain in outpatient medicine

    Learn more about this trial

    Evaluation of the Efficacy and Safety of Fentanyl Delivered by Adhesive Skin Patch in Out-Patients With Chronic Cancer Pain

    We'll reach out to this number within 24 hrs