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

NCT04186442 | Completed Phase 1

• 1 other identifier: HG-BOTOAB-PI-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Urinary incontinence rate

  Baseline to Week 2, Week 6, Week 12

• Voiding frequency rate

  Baseline to Week 2, Week 6, Week 12

• Urinary urgency rate

  Baseline to Week 2, Week 6, Week 12

Study Arms (2)

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]

Interventions

Botulinum toxin type A injection DRUG

Experimental

Also known as: Botulax®

Botulinum toxin type A (Botulax®)

Botulinum Toxin Type A Injection [Botox] DRUG

Active Comparator

Also known as: Botox®

Botulinum toxin type A (Botox®)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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\*
• \* 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

Sponsors & Collaborators

• Hugel: lead

Study Sites (1)

Hugel

Seoul, Korea, 06162, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: May 12, 2020
• Primary Completion: April 26, 2021
• Study Completion: October 26, 2021
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

KR (1)