Overactive BladderPhase 3NCT04113941
Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder
A Phase 3 study testing Neuronox in people with Overactive Bladder, run by Medy-Tox at 1 site in South Korea.
Trial summary
This study is for patients who have idiopathic overactive bladder symptoms. This study will evaluate efficacy and safety of Neuronox® against placebo. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Neuronox
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Aug 2019to Aug 2021
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged above 20
- Patient with overactive bladder symptoms lasting at least 6 months
Who cannot join
- Patient with a history of surgery or a disease that may affect bladder function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder
This study is for patients who have idiopathic overactive bladder symptoms. This study will evaluate efficacy and safety of Neuronox® against placebo.
- Conditions
- Overactive Bladder
- Being tested
- Neuronox, Placebo
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuronoxDrug
Also called Meditoxin
intradetrusor injection
PlaceboDrug
intradetrusor injection
| Study group | Role | What they receive |
|---|---|---|
| Neuronox® | Experimental | Neuronox® total 100U, inject 5U/0.5mL per site, 20 sites Receives: Drug: Neuronox |
| Placebo | Placebo comparator | Normal saline, same volume with Experimental arm Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the daily average UI (Urinary Incontinence) episodes
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start23 Aug 2019
- Primary completion15 Apr 2020
- Study completionAug 2021 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113941
- Sponsor's protocol ID
- MT01-KR17OAB302
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2019
- Last updated
- 28 Jul 2020
- 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 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of MEDITOXIN® in Subject With Idiopathic Overactive Bladder
- ClinicalTrials.gov ID
- NCT04113941
- Acronym / sponsor ID
- MT01-KR17OAB302
- Conditions
- Overactive Bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- Aug 2021 (estimated)
- First posted
- 3 Oct 2019 (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.
This study is for patients who have idiopathic overactive bladder symptoms. This study will evaluate efficacy and safety of Neuronox® against placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuronox® | Experimental | Drug: NeuronoxNeuronox® total 100U, inject 5U/0.5mL per site, 20 sites |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline, same volume with Experimental arm |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female subjects aged above 20
- Patient with overactive bladder symptoms lasting at least 6 months
Key exclusion criteria (1 listed)
- Patient with a history of surgery or a disease that may affect bladder function.
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 |
|---|---|---|
| NeuronoxAlso: Meditoxinintradetrusor injection | Drug | Neuronox® |
| Placebointradetrusor injection | Drug | Placebo |
Primary outcome
The change in the daily average UI (Urinary Incontinence) episodes
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Neuronox in people with Overactive Bladder, run by Medy-Tox at 1 site 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 2 inclusion and 1 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 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the daily average UI (Urinary Incontinence) episodes (time frame: 12 weeks). 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 28 Jul 2020.