UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043848 |
|---|---|
| Receipt number | 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 02:22:55 |
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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
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
mohamadamoussa@hotmail.com
Sponsor or person
Institute
Al Zahraa Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050047
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