Overactive BladderPhase 1NCT04186442
Evaluate the Safety and Efficacy of Botulax® Versus Botox® in Patient With Overactive Bladder
A Phase 1 study testing Botulinum toxin type A injection and Botulinum Toxin Type A Injection [Botox] in people with Overactive Bladder, run by Hugel at 1 site in South Korea.
Trial summary
To determine the efficacy and safety of Botulax® in treatment of Overactive Bladder Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Botulinum toxin type A injection and Botulinum Toxin Type A Injection [Botox]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 May 2020to 26 Oct 2021
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female at the age of 19 or older
- Subjects who agree to participate in the clinical study and voluntarily sign the written informed consent form
- Subjects with idiopathic overactive bladder who meets the following conditions:
- Subjects with persistent overactive bladder symptoms for the last 12 weeks
- Subjects who are not properly controlled by the administration of anticholinergic agents for 4 weeks or more or who are difficult to treat due to adverse reactions
- Subjects with urinary incontinence, urgency, and urinary frequency symptoms
- Subjects who are willing to perform clean intermittent catheterization (CIC), if needed
Who cannot join
- Subjects who are eligible for any of the following conditions may not participate in this study:
- Subjects with the following comorbidities:
- Subjects with peripheral motor neuron disease (eg. amyotrophic lateral sclerosis, motor neuropathy) or systemic neuromuscular junction disorders (eg. myasthenia gravis, Lambert-Eaton syndrome)
- Overactive bladder patients due to neurological factors (eg stroke, spinal cord disease, Parkinson's disease, etc.)
- Subjects with clinically significant stress incontinence
- Subjects with Urinary Tract Infections*
Show all 22Show fewer
- Culture showing ≥10^5 colony-forming units (CFU)/mL and leukocytes ≥5 high power field (HPF)
- Patients with acute urinary retention, or with a history or accompanying diseases that can cause urinary retention (urolithiasis, acute cystitis, foreign body in the bladder, bladder flow, etc.)
- Uncontrolled diabetes patients who meet one or more of the following criteria:
- HbA1c ≥ 9% at screening
- Patients with over 10 years of diabetes
- Have diabetic chronic complications (eg diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc.)
- Patients taking a drug that causes glycosuria (sodium-glucose co-transporter 2 inhibitor, SGLT2 inhibitor)
- Those who have had lower urinary tract surgery within 24 weeks before screening
- Those who received botulinum toxin due to urinary system disease within 24 weeks before screening
- Those who have been administered botulinum toxin type A within 12 weeks prior to screening or botulinum toxin type B within 16 weeks of treatment, or planned during the clinical trials
- Those who have received or plan to receive oral medications for overactive bladder including anticholinergic drugs within 1 week prior to randomization
- Those who received antiplatelet and anticoagulants within 1 week prior to randomization
- Subjects with a history of hypersensitivity reactions to any of the components of the investigational product
- Women of childbearing potential who are planning to become pregnant during the clinical trials or are not using an appropriate method of contraception
- Those who participated in another clinical trial within 12 weeks prior to screening and received investigational product/medical device/medical procedure
- Those who are sensitive to cephalosporin or penicillin antibiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase I Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patient With Overactive Bladder
To determine the efficacy and safety of Botulax® in treatment of Overactive Bladder
Read the detailed description
A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase I Clinical Trial to Compare the Safety and Efficacy of Botulax® versus Botox® in Patient with Overactive Bladder
- Conditions
- Overactive Bladder
- Being tested
- Botulinum toxin type A injection, Botulinum Toxin Type A Injection [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.
Botulinum toxin type A injectionDrug
Also called Botulax®
Experimental
Botulinum Toxin Type A Injection [Botox]Drug
Also called Botox®
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A (Botulax®) | Experimental | Not described Receives: Drug: Botulinum toxin type A injection |
| Botulinum toxin type A (Botox®) | Active comparator | Not described Receives: Drug: Botulinum Toxin Type A Injection [Botox] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event incidence rates
To assess severity and frequency of reported TEAE (treatment-emergent adverse event), ADR (adverse drug reaction), and SAE (serious adverse event) after investigational product injection
Measured: 12 weeks (during the clinical trial)
Secondary outcomes (3)
Urinary incontinence rate
The change in the average number of Urinary incontinence per day at 2, 6 and 12 weeks from baseline
Measured: Baseline to Week 2, Week 6, Week 12
Voiding frequency rate
The change in the average number of voiding frequency per day at 2, 6 and 12 weeks from baseline
Measured: Baseline to Week 2, Week 6, Week 12
Urinary urgency rate
The change in the average number of urinary urgency (Urgency Rating Scale; URS≥2)per day at 2, 6 and 12 weeks from baseline
Measured: Baseline to Week 2, Week 6, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start12 May 2020
- Primary completion26 Apr 2021
- Study completion26 Oct 2021
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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186442
- Sponsor's protocol ID
- HG-BOTOAB-PI-01
- Status last verified
- Apr 2022
- First submitted
- 2 Dec 2019
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase I Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patient With Overactive Bladder
- ClinicalTrials.gov ID
- NCT04186442
- Acronym / sponsor ID
- HG-BOTOAB-PI-01
- Conditions
- Overactive Bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Study start
- 12 May 2020 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 4 Dec 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.
To determine the efficacy and safety of Botulax® in treatment of Overactive Bladder
Detailed description
A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase I Clinical Trial to Compare the Safety and Efficacy of Botulax® versus Botox® in Patient with Overactive Bladder
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin type A (Botulax®) | Experimental | Drug: Botulinum toxin type A injection |
| Botulinum toxin type A (Botox®) | Active comparator | Drug: Botulinum Toxin Type A Injection [Botox] |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female at the age of 19 or older
- Subjects who agree to participate in the clinical study and voluntarily sign the written informed consent form
- Subjects with idiopathic overactive bladder who meets the following conditions:
- Subjects who are willing to perform clean intermittent catheterization (CIC), if needed
Key exclusion criteria (22 listed)
- Subjects who are eligible for any of the following conditions may not participate in this study:
- Subjects with the following comorbidities:
- Those who have had lower urinary tract surgery within 24 weeks before screening
- Those who received botulinum toxin due to urinary system disease within 24 weeks before screening
- Those who have been administered botulinum toxin type A within 12 weeks prior to screening or botulinum toxin type B within 16 weeks of treatment, or planned during the clinical trials
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 |
|---|---|---|
| Botulinum toxin type A injectionAlso: Botulax®Experimental | Drug | Botulinum toxin type A (Botulax®) |
| Botulinum Toxin Type A Injection [Botox]Also: Botox®Active Comparator | Drug | Botulinum toxin type A (Botox®) |
Primary outcome
Adverse event incidence rates
Time frame: 12 weeks (during the clinical trial)
To assess severity and frequency of reported TEAE (treatment-emergent adverse event), ADR (adverse drug reaction), and SAE (serious adverse event) after investigational product injection
3 secondary outcomes
Urinary incontinence rate
Time frame: Baseline to Week 2, Week 6, Week 12
Voiding frequency rate
Time frame: Baseline to Week 2, Week 6, Week 12
Urinary urgency rate
Time frame: Baseline to Week 2, Week 6, Week 12
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 15 Apr 2022.
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
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 Botulinum toxin type A injection and Botulinum Toxin Type A Injection [Botox] in people with Overactive Bladder, run by Hugel 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 7 inclusion and 22 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 15 Apr 2022. 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?
Adverse event incidence rates (time frame: 12 weeks (during the clinical trial)). 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 15 Apr 2022.