Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women
NCT02981459 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2020-10-22
Summary
The specific purpose of this study is to provide objective data in prospective open label design (n=40) to support the use of Mirabegron as a treatment for pain related urinary frequency and urgency. Women with bladder pain have a poor response to traditional anticholinergic therapy for their symptoms of frequency and urgency.
Conditions
- Urinary Frequency/Urgency
- Bladder Irritable
- Bladder Pain Syndrome
Interventions
- DRUG
-
Mirabegron
daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks
Sponsors & Collaborators
-
Astellas Pharma Inc
collaborator INDUSTRY -
State University of New York at Buffalo
lead OTHER
Principal Investigators
-
Tova S Ablove, MD · University at Buffalo
-
Vanessa Barnabei, MD PHD · University at Buffalo
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 89 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-08
- Primary Completion
- 2018-06-30
- Completion
- 2018-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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