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A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada

Sponsor
Allergan (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04567095
Collaborator
(none)
0
Enrollment
1
Location
8
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Patients in Canada.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Data will be collected via web-based data capture and paper surveys depending on patient preference. The survey will be conducted in a single wave over 6 months. All data will be maintained in compliance with local regulations.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    A Cross-sectional Study Among Patients in Canada to Assess Awareness and Knowledge of the Fibristal Patient Alert Card
    Anticipated Study Start Date :
    Oct 31, 2020
    Anticipated Primary Completion Date :
    Jun 30, 2021
    Anticipated Study Completion Date :
    Jun 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Percentages of patients with correct responses to the knowledge related questions based on the contents of the Fibristal Patient Alert Card. [18 - 24 months]

      Correct responses to knowledge-related questions (i.e, potential of fibristal to cause liver injury, signs and symptoms of liver problems, and what to do in case of signs and symptoms of liver problems.)

    Secondary Outcome Measures

    1. Percentages of patients that recall recieving and using the Fibristal Patient Alert Card [18 - 24 months]

      Receipt and use of the Fibristal Patient Alert Card,

    2. Percentage of patients that recall their HCPs' ordering of required liver function tests in accordance with the recommendations in the aRMM/CPM [18 - 24 months]

      Timing and frequency of liver testing conducted by the patients's HCP

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who have received Fibristal within 6 months of completing the survey.

    • Patients who have provided permission to share their responses in aggregate with Health Canada.

    • Patients who have provided informed consent for their participation in the survey.

    Exclusion Criteria:

    • Patients who participated in the cognitive pre-testing of the survey questionnaire to be used for the study.

    • Patients who have been direct employees of Allergan, ICON, Health Canada, or Professional Targeted Marketing (PTM) within the past year.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Trials Registry Team Irvine California United States 92622

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Ahunna Ukah, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT04567095
    Other Study ID Numbers:
    • CMO-EPI-WH-0626
    First Posted:
    Sep 28, 2020
    Last Update Posted:
    Oct 23, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leiomyoma

    Study Results

    No Results Posted as of Oct 23, 2020