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Evaluate the Safety and Efficacy of Botulax® Versus Botox® in Patient With Overactive Bladder

Sponsor
Hugel (Industry)
Overall Status
Completed
CT.gov ID
NCT04186442
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
17.5
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the efficacy and safety of Botulax® in treatment of Overactive Bladder

Condition or Disease Intervention/Treatment Phase
  • Drug: Botulinum toxin type A injection
  • Drug: Botulinum Toxin Type A Injection [Botox]
 Phase 1

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

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 12, 2020
Actual Primary Completion Date :
Apr 26, 2021
Actual Study Completion Date :
Oct 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Botulinum toxin type A (Botulax®)

Drug: Botulinum toxin type A injection
Experimental
Other Names:
  • Botulax®

    		•
    Active Comparator: Botulinum toxin type A (Botox®)

    Drug: Botulinum Toxin Type A Injection [Botox]
    Active Comparator
    Other Names:
  • Botox®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse event incidence rates [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

    Secondary Outcome Measures

    1. Urinary incontinence rate [Baseline to Week 2, Week 6, Week 12]

      The change in the average number of Urinary incontinence per day at 2, 6 and 12 weeks from baseline

    2. Voiding frequency rate [Baseline to Week 2, Week 6, Week 12]

      The change in the average number of voiding frequency per day at 2, 6 and 12 weeks from baseline

    3. Urinary urgency rate [Baseline to Week 2, Week 6, Week 12]

      The change in the average number of urinary urgency (Urgency Rating Scale; URS≥2)per day at 2, 6 and 12 weeks from baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Female at the age of 19 or older

    2. Subjects who agree to participate in the clinical study and voluntarily sign the written informed consent form

    3. Subjects with idiopathic overactive bladder who meets the following conditions:

    4. Subjects with persistent overactive bladder symptoms for the last 12 weeks

    5. 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

    6. Subjects with urinary incontinence, urgency, and urinary frequency symptoms

    7. Subjects who are willing to perform clean intermittent catheterization (CIC), if needed

    Exclusion Criteria:

    Subjects who are eligible for any of the following conditions may not participate in this study:

    1. Subjects with the following comorbidities:

    2. Subjects with peripheral motor neuron disease (eg. amyotrophic lateral sclerosis, motor neuropathy) or systemic neuromuscular junction disorders (eg. myasthenia gravis, Lambert-Eaton syndrome)

    3. Overactive bladder patients due to neurological factors (eg stroke, spinal cord disease, Parkinson's disease, etc.)

    4. Subjects with clinically significant stress incontinence

    5. Subjects with Urinary Tract Infections*

    • Culture showing ≥10^5 colony-forming units (CFU)/mL and leukocytes ≥5 high power field (HPF)

    1. 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.)

    2. 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)

    1. Those who have had lower urinary tract surgery within 24 weeks before screening

    2. Those who received botulinum toxin due to urinary system disease within 24 weeks before screening

    3. 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

    4. Those who have received or plan to receive oral medications for overactive bladder including anticholinergic drugs within 1 week prior to randomization

    5. Those who received antiplatelet and anticoagulants within 1 week prior to randomization

    6. Subjects with a history of hypersensitivity reactions to any of the components of the investigational product

    7. Women of childbearing potential who are planning to become pregnant during the clinical trials or are not using an appropriate method of contraception

    8. Those who participated in another clinical trial within 12 weeks prior to screening and received investigational product/medical device/medical procedure

    9. Those who are sensitive to cephalosporin or penicillin antibiotics

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hugel Seoul Korea Korea, Republic of 06162

    Sponsors and Collaborators

    • Hugel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hugel
    ClinicalTrials.gov Identifier:
    NCT04186442
    Other Study ID Numbers:
    • HG-BOTOAB-PI-01
    First Posted:
    Dec 4, 2019
    Last Update Posted:
    Apr 15, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Urinary Bladder, Overactive
    Botulinum Toxins
    Botulinum Toxins, Type A
    abobotulinumtoxinA

    Study Results

    No Results Posted as of Apr 15, 2022