Therapeutic Efficacy and Safety of Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan

NCT03044912 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: TCGHUROL012
• Study Type: interventional
• Target: 574
• Locations: 1 country
• Sites: 1

Brief Summary

Recent phase III trials have confirmed the efficacy and safety of mirabegron in the treatment of overactive bladder (OAB) in Europeans, Australians, North Americans, Japanese and Asians. Whether mirabegron 25mg or 50mg should be used as the first line treatment for OAB has not been determined yet. The dose effectiveness relationship between 25mg and 50mg mirabegron has also not been investigated yet. Hence, investigators have conducted this post marketing study in order to evaluate the efficacy and safety between mirabegron 25mg and 50mg in Taiwanese people with symptoms of OAB.

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (1)

• Changes of urgency episodes by 2 per 24 hours

  The percentage of patients with a change from baseline to the final visit in the urgency episodes per 24 hours by 2 or greater

  baseline and 3 months

Secondary Outcomes (8)

• Net change of overactive bladder symptom score (OABSS)

  baseline and 3 months

• Patient Perception on Intensity of Urgency Scale (PPIUS)

  baseline and 3 months

• Net change of mean number of frequency episodes

  baseline and 3 months

• The net change of mean number of urinary incontinence episodes

  baseline and 3 months

• Net change of the mean number of urgency incontinence episodes

  baseline and 3 months

Study Arms (2)

treatment group

EXPERIMENTAL

Mirabegron 50 mg for comparison

Drug: mirabegron

Comparative group

ACTIVE COMPARATOR

Patient take Mirabegron 25 mg

Drug: mirabegron

Interventions

mirabegron DRUG

To evaluate the efficacy and safety of Mirabegron 50 mg vs 25 mg in Taiwanese patients with overactive bladder syndrome

Also known as: Betmiga

Comparative group; treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptoms of OAB for at least 12 weeks before initiation of the run-in period;
• an average of ≥8 micturitions per 24 hours,
• an average of ≥2 episode of urgency or urgency incontinence per 24-hours, during a 3-day micturition diary period.
• no prior pharmacological treatment for OAB

You may not qualify if:

• stress urinary incontinence as a predominant symptom at screening;
• urinary tract infection, urinary stone, interstitial cystitis or a history of recurrent urinary tract infection;
• confirmed post-void residual (PVR) volume of ≥100 mL or more or with a clinically significant lower urinary tract obstructive disease;
• proven neurogenic bladder such as spinal cord injury, multiple sclerosis;
• overt bladder outlet obstruction.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, 970, Taiwan

RECRUITING

MeSH Terms

Interventions

mirabegron

Study Officials

• Hann-Chorng Kuo, M.D.

  Buddhist Tzu Chi General Hospital, Hualien, Taiwan

  STUDY DIRECTOR

Central Study Contacts

Hann-Chorng Kuo, M.D.

CONTACT

886-3-8561825; hck@tzuchi.com.tw

Dong-Ling Tang

CONTACT

886-3-8561825; hck@tzuchi.com.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman and Professor, Department of Urology

Model Details: Randomized open label study

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 7, 2017
• Study Start: November 16, 2015
• Primary Completion: February 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)