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

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Botulinum toxin type A injection; Drug: Botulinum Toxin Type A Injection [Botox]

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Korea
    • Seoul, Korea, Korea, Republic of, 06162
      • Hugel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

   1. Subjects with persistent overactive bladder symptoms for the last 12 weeks
   2. 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
   3. Subjects with urinary incontinence, urgency, and urinary frequency symptoms
4. 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:

   1. Subjects with peripheral motor neuron disease (eg. amyotrophic lateral sclerosis, motor neuropathy) or systemic neuromuscular junction disorders (eg. myasthenia gravis, Lambert-Eaton syndrome)
   2. Overactive bladder patients due to neurological factors (eg stroke, spinal cord disease, Parkinson's disease, etc.)
   3. Subjects with clinically significant stress incontinence

   4. Subjects with Urinary Tract Infections*

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

   5. 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.)

   6. 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)
2. Those who have had lower urinary tract surgery within 24 weeks before screening
3. Those who received botulinum toxin due to urinary system disease within 24 weeks before screening
4. 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
5. Those who have received or plan to receive oral medications for overactive bladder including anticholinergic drugs within 1 week prior to randomization
6. Those who received antiplatelet and anticoagulants within 1 week prior to randomization
7. Subjects with a history of hypersensitivity reactions to any of the components of the investigational product
8. Women of childbearing potential who are planning to become pregnant during the clinical trials or are not using an appropriate method of contraception
9. Those who participated in another clinical trial within 12 weeks prior to screening and received investigational product/medical device/medical procedure
10. Those who are sensitive to cephalosporin or penicillin antibiotics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks (during the clinical trial)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary incontinence rate	The change in the average number of Urinary incontinence per day at 2, 6 and 12 weeks from baseline	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	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	Baseline to Week 2, Week 6, Week 12

Collaborators and Investigators

• Sponsor: Hugel

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2020
• Primary Completion (Actual): April 26, 2021
• Study Completion (Actual): October 26, 2021

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: HG-BOTOAB-PI-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No