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

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: NCT03044912
Recruitment Status : Unknown
Verified February 2017 by Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital.
Recruitment status was:  Recruiting
First Posted : February 7, 2017
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Hann-Chorng Kuo, Buddhist Tzu Chi General Hospital

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Syndrome Drug: mirabegron Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 574 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized open label study
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Therapeutic Efficacy and Safety of Mirabegron , a β3-Adrenoceptor Agonist, Treatment on Patients With Overactive Bladder Syndrome in Taiwan - Comparison of Therapeutic Efficacy and Safety Between 25mg and 50mg
Actual Study Start Date : November 16, 2015
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Mirabegron

Arm Intervention/treatment
Experimental: treatment group
Mirabegron 50 mg for comparison
Drug: mirabegron
To evaluate the efficacy and safety of Mirabegron 50 mg vs 25 mg in Taiwanese patients with overactive bladder syndrome
Other Name: Betmiga

Active Comparator: Comparative group
Patient take Mirabegron 25 mg
Drug: mirabegron
To evaluate the efficacy and safety of Mirabegron 50 mg vs 25 mg in Taiwanese patients with overactive bladder syndrome
Other Name: Betmiga




Primary Outcome Measures :
  1. Changes of urgency episodes by 2 per 24 hours [ Time Frame: baseline and 3 months ]
    The percentage of patients with a change from baseline to the final visit in the urgency episodes per 24 hours by 2 or greater


Secondary Outcome Measures :
  1. Net change of overactive bladder symptom score (OABSS) [ Time Frame: baseline and 3 months ]
    Net change from baseline to the final visit in OABSS score

  2. Patient Perception on Intensity of Urgency Scale (PPIUS) [ Time Frame: baseline and 3 months ]
    Net change of Patient Perception on Intensity of Urgency Scale (PPIUS) from baseline to the final visit

  3. Net change of mean number of frequency episodes [ Time Frame: baseline and 3 months ]
    The net change of mean number of frequency episodes from baselinbe to the final visit

  4. The net change of mean number of urinary incontinence episodes [ Time Frame: baseline and 3 months ]
    The net change of mean number of urinary incontinence episodes from baseline to the final visit

  5. Net change of the mean number of urgency incontinence episodes [ Time Frame: baseline and 3 months ]
    Net change of the mean number of urgency incontinence episodes from baseline to the final visit

  6. The net change of mean number of nocturia episodes per 24 hours [ Time Frame: baseline and 3 months ]
    The net change of mean number of nocturia episodes per 24 hours from baselinev to the final visit

  7. The net change of mean volume voided per micturition [ Time Frame: baseline and 3 months ]
    The net change of mean volume voided per micturition from baseline to the final visit

  8. The net change of the Patient Perception of the Bladder Condition (PPBC) [ Time Frame: baseline and 3 months ]
    The net change in the Patient Perception of the Bladder Condition (PPBC) from baseline to final visit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT03044912


Contacts
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Contact: Hann-Chorng Kuo, M.D. 886-3-8561825 ext 2113 hck@tzuchi.com.tw
Contact: Dong-Ling Tang 886-3-8561825 ext 2117 hck@tzuchi.com.tw

Locations
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Taiwan
Buddhist Tzu Chi General Hospital Recruiting
Hualien, Taiwan, 970
Contact: Hann-Chorng Kuo, M.D.    886-3-8561825 ext 2113    hck@tzuchi.com.tw   
Contact: Dong-Ling Tang, Miss    886-3-8561825 ext 2117    don_lin86@yahoo.com.tw   
Sponsors and Collaborators
Buddhist Tzu Chi General Hospital
Investigators
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Study Director: Hann-Chorng Kuo, M.D. Buddhist Tzu Chi General Hospital, Hualien, Taiwan
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Responsible Party: Hann-Chorng Kuo, Chairman and Professor, Department of Urology, Buddhist Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT03044912    
Other Study ID Numbers: TCGHUROL012
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD is not planned to be available

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Syndrome
Disease
Pathologic Processes
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Mirabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents