A Study to Evaluate Awareness and Knowledge of the Fibris... | NCT04567095

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

NCT04567095

Sponsor

Allergan

Status

Withdrawn

Last Update Posted

Oct 23, 2020Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Uterine Fibroids

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was cancelled before any data collection due to business reasons.

Expanded Access Info

Start Date

Oct 31, 2020Estimated

Primary Completion Date

Jun 30, 2021Estimated

Completion Date

Jun 30, 2021Estimated

First Submitted Date

Sep 1, 2020

First Submission Date that Met QC Criteria

Sep 23, 2020

First Posted Date

Sep 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2020

Last Update Posted Date

Oct 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentages of patients with correct responses to the knowledge related questions based on the contents of the Fibristal Patient Alert Card.	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.)	18 - 24 months

Secondary Outcomes

Measure	Description	Time Frame
Percentages of patients that recall recieving and using the Fibristal Patient Alert Card	Receipt and use of the Fibristal Patient Alert Card,	18 - 24 months
Percentage of patients that recall their HCPs' ordering of required liver function tests in accordance with the recommendations in the aRMM/CPM

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The survey will endeavor to collect 150 completed patient surveys

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahunna Ukah	Allergan	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trials Registry Team		Irvine	California	92622	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

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/.

Types

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/

Condition Browse Module

MeSH Terms

ID	Term
D007889	Leiomyoma

Ancestor Terms

ID	Term
D009379	Neoplasms, Muscle Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided