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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04567095
Recruitment Status : Withdrawn (This study was cancelled before any data collection due to business reasons.)
First Posted : September 28, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

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
Uterine Fibroids

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.

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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
Estimated Study Start Date : October 31, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine





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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 18 - 24 months ]
    Timing and frequency of liver testing conducted by the patients's HCP



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The survey will endeavor to collect 150 completed patient surveys
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567095


Locations
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United States, California
Clinical Trials Registry Team
Irvine, California, United States, 92622
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Ahunna Ukah Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT04567095    
Other Study ID Numbers: CMO-EPI-WH-0626
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms