A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
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ClinicalTrials.gov Identifier: NCT04567095
Recruitment Status :
(This study was cancelled before any data collection due to business reasons.)
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
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.
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 :
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,
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
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Gender Based Eligibility:
Accepts Healthy Volunteers:
The survey will endeavor to collect 150 completed patient surveys
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.
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.
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
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/.
Clinical Study Report (CSR)
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.
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.
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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:
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Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type