Overactive BladderPhase 4NCT03412513
Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease
A Phase 4 study testing Mirabegron in people with Overactive Bladder and Parkinson Disease, run by Seoul National University Hospital at 5 sites in South Korea.
Trial summary
The purpose of this study is to see the study drug, Mirabegron, is safe and effective in treating symptoms of Overactive Bladder in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Overactive Bladder, Parkinson Disease
- What is being tested?
- Mirabegron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 17 Jul 2017to 31 Dec 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who signed a consent form approved from IRB(Institutional Review Board) or IEC(Independent Ethics Committee)
- Diagnosis of Parkinson's disease by a neurologist
- taking a Parkinson's medications stably during 4 weeks preceding screening
- 40 Years to 80 Years, Male and Female
- Patient has overactive bladder symptoms more than 4 weeks preceding screening.
- OABSS questionnaires total score≥ 3 and entries of urinary urgency score≥ 2
- The expanded disability status scale ≤ 7
Who cannot join
- Subjects who have any intervention and operation which can influence on study such as bladder augmentation, vesical sphincter, artificial sphincter, intravesical botulinum toxin treatment etc.
- Use of indwelling catheter or self-catheterization
- acute urinary tract infection or urolithiasis at screening
- History of chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
- total volume urine > 3L a day
- Screening post-void residual > 200ml
Show all 16Show fewer
- Nonpharmacological therapy within the previous 4 weeks of screening
- screening blood pressure >180 systolic or 110 diastolic
- subjects who have orthostatic hypotension, syncope, hypokalemia, or angle-closure glaucoma
- Clinically Significant ECG in recent year
- Screening estimated glomerular filtration rate (eGFR) < 29, AST ( aspartate aminotransferase ) or ALT ( alanine aminotransferase ) > 2x upper limit of normal, γ-GT(gamma-glutamyl transferase) > 3xULN
- take following medication additionally or change the dose: previous 4weeks of screening to end of the study (tamsulosin/silodosin/terazosin, baclofen, diazepam, amitriptyline, DDAVP/desmopressin) previous 12weeks of screening to end of the study (finasteride, dutasteride)
- Use β2- adrenoreceptor agonist, loop diuretic, CYP 3A4 inducer, CYP 2D6 narrow therapeutic index, CYP 3A4 inhibitor, antifungal agent, antiarrhythmic agent
- History of allergy to Mirabegron and beta-adrenergic receptor
- Use of one of the anti-cholinergic bladder medications such as Propiverine / tolterodine / trospium / darifenacin / solifenacin / fesoterodine and mirabegron within 14 days of the screening visit. Subjects who have used one of these medications in the past but discontinued it at least 14 days prior to the screening visit can be enrolled.
- women who have potential to become pregnant during the course of the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Kyungpook National University Hospital
Daegu
Eun Sang Yoo, MD, +82-53-420-5851, uroyoo@knu.ac.kr
- Recruiting
Hallym University Medical Center
Gyeonggi-do
Sung Ho Lee, MD, +82-31-8086-2854, shleeuro@hallym.or.kr
- Recruiting
Seoul National University Bundang Hospital
Gyeonggi-do
Sang Chul Lee, MD, slee@snubh.org
- Recruiting
Severance Hospital
Seoul
Jang Hwan Kim, MD, jkim@yuhs.ac
- Recruiting
SMG-SNU Boramae Medical Center
Seoul
Sung Yong Cho, MD, +82-2-870-2394, moretry@yahoo.com
About this study
Official title: Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease: a Double-blind, Randomized Placebo-controlled Trial
The purpose of this study is to see the study drug, Mirabegron, is safe and effective in treating symptoms of Overactive Bladder in patients with Parkinson's disease.
Read the detailed description
This study is a randomized 1:1 placebo-controlled 12-week study of Mirabegron in 144 Parkinson's subjects the age of 40 to 80 with overactive bladder. Active drug will be Mirabegron 50mg daily. Subjects will be enrolled based on response to an overactive bladder questionnaire at visit 1. Enrolled subjects will have 3 study visits to the clinic as well as 1 phone visit.
- Conditions
- Overactive Bladder, Parkinson Disease
- Being tested
- Mirabegron, Placebo
- Keywords
- Overactive Bladder, Parkinson Disease
- Medical subject headings
- Urinary Bladder, Overactive, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronDrug
Also called Betmiga PR 50mg
Mirabegron 50mg po daily for 12 weeks to Active Comparator group, and 4 weeks(from visit 4 to visit 5) to Placebo comparator group.
PlaceboDrug
Also called sugar pill
Placebo po daily for 8 weeks to Placebo comparator group.
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron | Active comparator | 1:1 randomization to receive Mirabegron 50mg daily or placebo at visit 2. At visit 4 all subjects will receive Mirabegron 50mg. Receives: Drug: Mirabegron |
| Placebo | Placebo comparator | 1:1 randomization to receive Mirabegron 50mg daily or placebo at visit 2. At visit 4 all subjects will receive Mirabegron 50mg. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the total score of Overactive Bladder Symptom Scale(OABSS)
Change in the total score of Overactive Bladder Symptom Scale(OABSS) from baseline(Visit 2) to Visit 4
Measured: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Secondary outcomes (10)
Change in the total score of OABSS(Overactive Bladder Symptom Scale)
Change in the total score of OABSS, Visit 3, Visit 4 and Visit 5
Measured: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of IPSS(International Prostate Symptom Score)
Change in the total score of IPSS and bothersome score, Visit 3, Visit 4 and Visit 5
Measured: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of OAB-q short form
Change in the total score of OAB-q short form,Visit 3, Visit 4 and Visit 5
Measured: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of PPBC(Patient Perception of Bladder Condition)
Change in the total score of PPBC, Visit 3, Visit 4 and Visit 5
Measured: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of TSQ (Treatment Satisfaction Questionnaire)
Change in the total score of TSQ, Visit 3, Visit 4 and Visit 5
Measured: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of GRA (Global Response Assessment)
Change in the total score of GRA, Visit 3, Visit 4 and Visit 5
Measured: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the score of BSW (Benefit, Satisfaction and Willingness to Continue Questions)
Change in the score of BSW, Visit 4 and Visit 5
Measured: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the Mean Frequent Urination
Change in the Mean Frequent Urination, Visit 3 and Visit 4
Measured: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the Mean number of Urinary urgency
Change in the Mean number of Urinary urgency, Visit 3 and Visit 4
Measured: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the Mean number of Urinary incontinence
Change in the Mean number of Urinary incontinence, Visit 3 and Visit 4
Measured: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start17 Jul 2017
- Primary completion16 Jul 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-June Oh, Seoul National University Hospital
- Investigators
- Seung-June Oh, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412513
- Sponsor's protocol ID
- PaDOMi Study
- Status last verified
- Jan 2018
- First submitted
- 21 Jan 2018
- Last updated
- 30 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease: a Double-blind, Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03412513
- Acronym / sponsor ID
- PaDOMi Study
- Conditions
- Overactive Bladder, Parkinson Disease
- Keywords
- Overactive Bladder, Parkinson Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 16 Jul 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see the study drug, Mirabegron, is safe and effective in treating symptoms of Overactive Bladder in patients with Parkinson's disease.
Detailed description
This study is a randomized 1:1 placebo-controlled 12-week study of Mirabegron in 144 Parkinson's subjects the age of 40 to 80 with overactive bladder. Active drug will be Mirabegron 50mg daily. Subjects will be enrolled based on response to an overactive bladder questionnaire at visit 1. Enrolled subjects will have 3 study visits to the clinic as well as 1 phone visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirabegron | Active comparator | Drug: Mirabegron1:1 randomization to receive Mirabegron 50mg daily or placebo at visit 2. At visit 4 all subjects will receive Mirabegron 50mg. |
| Placebo | Placebo comparator | Drug: Placebo1:1 randomization to receive Mirabegron 50mg daily or placebo at visit 2. At visit 4 all subjects will receive Mirabegron 50mg. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject who signed a consent form approved from IRB(Institutional Review Board) or IEC(Independent Ethics Committee)
- Diagnosis of Parkinson's disease by a neurologist
- taking a Parkinson's medications stably during 4 weeks preceding screening
- 40 Years to 80 Years, Male and Female
- Patient has overactive bladder symptoms more than 4 weeks preceding screening.
Key exclusion criteria (16 listed)
- Subjects who have any intervention and operation which can influence on study such as bladder augmentation, vesical sphincter, artificial sphincter, intravesical botulinum toxin treatment etc.
- Use of indwelling catheter or self-catheterization
- acute urinary tract infection or urolithiasis at screening
- History of chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
- total volume urine > 3L a day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirabegronAlso: Betmiga PR 50mgMirabegron 50mg po daily for 12 weeks to Active Comparator group, and 4 weeks(from visit 4 to visit 5) to Placebo comparator group. | Drug | Mirabegron |
| PlaceboAlso: sugar pillPlacebo po daily for 8 weeks to Placebo comparator group. | Drug | Placebo |
Primary outcome
Change in the total score of Overactive Bladder Symptom Scale(OABSS)
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of Overactive Bladder Symptom Scale(OABSS) from baseline(Visit 2) to Visit 4
10 secondary outcomes
Change in the total score of OABSS(Overactive Bladder Symptom Scale)
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of IPSS(International Prostate Symptom Score)
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of OAB-q short form
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of PPBC(Patient Perception of Bladder Condition)
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of TSQ (Treatment Satisfaction Questionnaire)
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the total score of GRA (Global Response Assessment)
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the score of BSW (Benefit, Satisfaction and Willingness to Continue Questions)
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the Mean Frequent Urination
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the Mean number of Urinary urgency
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Change in the Mean number of Urinary incontinence
Time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-June Oh, MD principal investigator
Seoul National University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirabegron in people with Overactive Bladder and Parkinson Disease, run by Seoul National University Hospital at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung-June Oh, MD (+82-2-2072-2421, sjo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the total score of Overactive Bladder Symptom Scale(OABSS) (time frame: Baseline(Visit 2 : 0 week), Visit 3(3-5 weeks post Visit 2), Visit 4(6-10 weeks post Visit 2), Visit 5(10-14 weeks post Visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.