Overactive BladderPhase 1NCT03371342
Treatment of MEDITOXIN® in Female Patients With Idiopathic Overactive Bladder
A Phase 1 study testing Meditoxin and Botox in people with Overactive Bladder, run by Medy-Tox at 1 site in South Korea.
Trial summary
To investigate the safety of MEDITOXIN in female subjects with idiopathic overactive bladder compared with BOTOX Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Meditoxin and Botox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Dec 2017to 5 Sep 2018
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female aged more than 20 years
- Subject who has symptoms of Overactive Bladder for a period of at least 6 months immediately prior to screening
Who cannot join
- Patient not appropriate for participating in this study according to the investigator's opinion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Active Controlled, Multi-center, Phase 1 Study to Investigate the Safety of MEDITOXIN® in Female Subjects With Idiopathic Overactive Bladder
To investigate the safety of MEDITOXIN in female subjects with idiopathic overactive bladder compared with BOTOX
- Conditions
- Overactive Bladder
- Being tested
- Meditoxin, Botox
- 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.
MeditoxinDrug
Meditoxin (Botulinum toxin type A)
BotoxDrug
Botox(Botulinum toxin type A)
| Study group | Role | What they receive |
|---|---|---|
| MEDITOXIN | Experimental | Not described Receives: Drug: Meditoxin |
| BOTOX | Active comparator | Not described Receives: Drug: Botox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in adverse events of MEDITOXIN at 12 week
safety profiles
Measured: baseline, week 12 follow up visits
Secondary outcomes (1)
Change from baseline in the daily average number of episodes of urinary incontinence
Urinary incontinence recorded by the participants in a bladder diary during the 3 consecutive days prior to the study visit.
Measured: baseline, week 12 follow up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start13 Dec 2017
- Primary completion31 May 2018
- Study completion5 Sep 2018
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 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
- NCT03371342
- Sponsor's protocol ID
- MT01-KR17OAB101
- Status last verified
- Mar 2019
- First submitted
- 28 Nov 2017
- Last updated
- 27 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active Controlled, Multi-center, Phase 1 Study to Investigate the Safety of MEDITOXIN® in Female Subjects With Idiopathic Overactive Bladder
- ClinicalTrials.gov ID
- NCT03371342
- Acronym / sponsor ID
- MT01-KR17OAB101
- Conditions
- Overactive Bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 5 Sep 2018 (actual)
- First posted
- 13 Dec 2017 (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.
To investigate the safety of MEDITOXIN in female subjects with idiopathic overactive bladder compared with BOTOX
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEDITOXIN | Experimental | Drug: Meditoxin |
| BOTOX | Active comparator | Drug: Botox |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female aged more than 20 years
- Subject who has symptoms of Overactive Bladder for a period of at least 6 months immediately prior to screening
Key exclusion criteria (1 listed)
- Patient not appropriate for participating in this study according to the investigator's opinion
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 |
|---|---|---|
| MeditoxinMeditoxin (Botulinum toxin type A) | Drug | MEDITOXIN |
| BotoxBotox(Botulinum toxin type A) | Drug | BOTOX |
Primary outcome
Change from baseline in adverse events of MEDITOXIN at 12 week
Time frame: baseline, week 12 follow up visits
safety profiles
1 secondary outcome
Change from baseline in the daily average number of episodes of urinary incontinence
Time frame: baseline, week 12 follow up visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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 1 study testing Meditoxin and Botox 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: finished, as of the sponsor's last update on 27 Mar 2019. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in adverse events of MEDITOXIN at 12 week (time frame: baseline, week 12 follow up visits). 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 27 Mar 2019.