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A Study on Anticholinergic Use: Attribution of Overactive Bladder (OAB) Medications to the Anticholinergic Burden

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: NCT03903094
Recruitment Status : Active, not recruiting
First Posted : April 4, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Singapore Pte. Ltd. )

Brief Summary:
Outpatients with at least one dispensing record of any medication will be included in the study. An index date will be assigned to each participant and prescription records for anticholinergics will be used in the study.

Condition or disease Intervention/treatment
Overactive Bladder (OAB) Other: Non-Interventional

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Study Type : Observational
Actual Enrollment : 6295279 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Database Analysis of Anticholinergic Burden Among the Elderly With and Without Overactive Bladder in Australia and South Korea
Actual Study Start Date : March 7, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Subjects With Overactive Bladder Treatment
Subjects who have dispensing records for treatment of overactive bladder will be included
Other: Non-Interventional
Overview of anticholinergic burden, rather than to evaluate specific drugs

Subjects Without Overactive Bladder Treatment
Subjects who do not have dispensing records for treatment of overactive bladder will be included
Other: Non-Interventional
Overview of anticholinergic burden, rather than to evaluate specific drugs




Primary Outcome Measures :
  1. Anticholinergic Cognitive Burden (ACB) score [ Time Frame: 100 days ]
    ACB will be calculated based on methodology from Campbell et al (2016). Sum (Drug A #days prescribed X ACB scale score) + (Drug B #days prescribed X ACB scale score) + (Drug X…)/Number of days with any medication prescribed. The cumulative score has a range from 0 to infinity, with higher values indicating a higher cumulative anticholinergic burden of the patient.


Secondary Outcome Measures :
  1. Median percentage of ACB score derived from overactive bladder (OAB) treatment(s) in total ACB score [ Time Frame: 100 days ]
    The attribution of antimuscarinics for OAB treatment to entire anticholinergic exposures in OAB patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Australian and Korean with at least one prescription of any treatment between January 22, 2016 and December 31, 2016 derived from country claims data.
Criteria

Inclusion Criteria:

  • Have at least one dispensing of any medication between January 22, 2016 and December 31, 2016.

Exclusion Criteria:

  • Participants who do not have a complete year of data availability in the database prior to index date.
  • Have record of hospitalization on the index date.

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): NCT03903094


Locations
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Australia
Site AU61001
Melbourne, Australia
Korea, Republic of
Site KR82001
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Singapore Pte. Ltd.
Investigators
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Study Director: Central Contact Astellas Pharma Global Development, Inc.
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Responsible Party: Astellas Pharma Singapore Pte. Ltd.
ClinicalTrials.gov Identifier: NCT03903094    
Other Study ID Numbers: 178-MA-3241
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Singapore Pte. Ltd. ):
anticholinergic burden
anticholinergic
overactive bladder
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations