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NCT01901120 Clinical Trial

Long-Term Specified Drug Use-results Survey of Betanis Tablets

Overactive Bladder Clinical Trial

Official title:
Long-Term Specified Drug Use-results Survey of Betanis Tablets

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01901120
Other study ID # BE0002
Secondary ID
Status Completed
Phase N/A
First received July 10, 2013
Last updated October 30, 2016
Start date October 2012
Est. completion date September 2016

Study information
Verified date October 2016
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial Summary

This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name: mirabegron), and to determine the adherence to treatment with mirabegron.

Recruitment information / eligibility
Status Completed
Enrollment 1263
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients who administer mirabegron for treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder and also who have no treatment history of mirabegron.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Betanis
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of adverse events Up to 36 months after treatment No
Secondary Overactive Bladder Symptom Score (OABSS) At the start of treatment and 3, 6, 12, 18, 24, 30, and 36 months after treatment No
See also
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Completed NCT01955408 - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment N/A
Recruiting NCT06201013 - Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children N/A
Recruiting NCT03727711 - TPTNS: Home vs Hospital Treatment for Overactive Bladder N/A
Completed NCT00768521 - A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107) Phase 1
Completed NCT03625843 - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing N/A
Completed NCT02211846 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder Phase 1
Completed NCT02835846 - Investigation of the Effect of the Female Urinary Microbiome on Incontinence Phase 4
Completed NCT02857816 - PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB N/A
Completed NCT02202031 - Controlling Urgency Through Relaxation Exercises N/A
Withdrawn NCT02320201 - Foot Neuromodulation for Overactive Bladder in Children N/A
Not yet recruiting NCT01409512 - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder N/A
Completed NCT01458197 - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder. Phase 2
Not yet recruiting NCT01423838 - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder Phase 4
Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
Withdrawn NCT01210859 - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents N/A
Completed NCT00928070 - A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder Phase 4