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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043848
Receipt No. R000050047
Scientific Title The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder : A randomized controlled trial
Date of disclosure of the study information 2021/04/29
Last modified on 2021/04/29

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Basic information
Public title The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder
Acronym SEMPDOAB
Scientific Title The safety and effectiveness of mirabegron in Parkinson's disease patients with overactive bladder : A randomized controlled trial
Scientific Title:Acronym SEMPDOABRCT
Region
Asia(except Japan)

Condition
Condition Overactive bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and effectiveness of mirabegron in patients with PD complaining of overactive bladder(OAB)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcomes of our study were the change from baseline in OAB symptom score, overactive bladder questionnaire short form score
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment group receiving daily mirabegron 50mg for 12 weeks
Interventions/Control_2 Placebo group
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Inclusion criteria for this study were patients with a clinical diagnosis of PD according to UK Brain Bank Criteria which demands bradykinesia and one additional symptom (rigidity, resting tremor, or postural instability). The diagnostic criteria were tested by a movement disorders specialist in the 12 months before receiving mirabegron therapy. Patients should be aged between 40 and 70 years, have a stable dose of antiparkinsonian drugs 8 weeks before study entry, stage 1 to 3 on modified Hoehn and Yahr scale. Patients received mirabegron 50 mg once daily, have post-void residue less than 100ml on an ultrasound of the bladder performed before study entry, patients were taking only levodopa or dopamine agonist at stable doses before entering the study, used at least for 12 weeks mirabegron 50mg and accomplish one visit of followup at the end of therapy.
Key exclusion criteria Exclusion criteria were patients with secondary parkinsonism syndromes, patients with polyuria with a daily urine volume more than 3000 mL, patients receiving monoamine oxidase B inhibitors and catecholOmethyltransferase (COMT) inhibitors for PD, patients operated previously by deep brain stimulation, patients taking anticholinergic medications for (overactive bladder) OAB symptoms, history of benign prostatic hypertrophy (males only), patients with stress urinary incontinence,
history of severe uncontrolled hypertensive patients (defined as systolic blood pressure more oe equal than 180 mm Hg and/or diastolic blood pressure more or equal than 110 mm Hg) or bladder outflow obstruction or gastrointestinal obstructive disorders, history of narrow-angle glaucoma, history of pelvic radiation. More exclusion criteria included: current treatment with digoxin, ketoconazole, drugs classified as CYP2D6 substrate, patients with a history of QT interval prolongation or taking drugs that prolong the QT interval, patients with severe renal impairment (GFR less than30ml per min) or moderate to severe hepatic impairment (ChildPugh B&C).
Target sample size 110

Research contact person
Name of lead principal investigator
1st name Mohamad
Middle name
Last name Abou Chakra
Organization Al Zahraa Hospital
Division name Urology
Zip code 1108
Address Beirut, Lebanon
TEL 0096171613732
Email mohamedabouchakra@hotmail.com

Public contact
Name of contact person
1st name Mohamad
Middle name
Last name Moussa
Organization Al Zahraa Hospital
Division name Urology
Zip code 1108
Address Beirut, Lebanon
TEL 00961964412
Homepage URL
Email mohamadamoussa@hotmail.com

Sponsor
Institute Al Zahraa Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Al zahraa Hospital
Address Beirut, Lebanon
Tel 009611851040ext3364
Email uroprog@gmail

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 95
Results There was a significant improvement in the primary outcome and secondary outcome measures in the treatment group compared to placebo group. Adverse events included constipation and xerostomia, which resolved after treatment was discontinued. Adverse events were mild .
Results date posted
2021 Year 04 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 12 Month 10 Day
Date of IRB
2016 Year 12 Month 16 Day
Anticipated trial start date
2017 Year 01 Month 10 Day
Last follow-up date
2020 Year 11 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 06 Day
Last modified on
2021 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050047

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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