A Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A in Patients With Overactive Bladder (OAB)

NCT02786407 | Unknown Phase 3 DMC

• 1 other identifier: HengLi004
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of Botulinus Toxin Type A for Injection (HengLi®) in patients with overactive bladder (OAB) . Approximately 216 subjects will be enrolled. Subjects will be randomized 2:1 to receive intradetrusor injection of Botulinus Toxin Type A for Injection (HengLi®) 100 U or placebo. The study contains two parts: core double-blinded phase and extension phase. In the core double-blinded phase, eligible subjects must attend three study visits posttreatment 12 weeks. During the extension phase, subjects must also attend three study visits (12 weeks). The primary efficacy variables is the change from baseline in the daily average frequency of micturition at week 6 after the first treatment.A 3-day paper bladder diary will be used before each study visits (screening period, the second week, the sixth week, the twelfth week, the fourteenth week, the eighteenth week and the twenty fourth week ) to collect all OAB symptoms (episodes of urgency, incontinence, micturition and nocturia) and volume per voidSafety parameters will also be measured, including adverse events, vital signs (pulse and blood pressure) and clinical laboratory tests (haematology, serum chemistry and urinanalysis).

Conditions

Overactive Bladder

Keywords

overactive bladder; Botulinum Toxin Type A for Injection

Outcome Measures

Primary Outcomes (1)

• average frequency of micturition

  The primary efficacy variables is the change from baseline in the daily average frequency of micturition at week 6 after the first treatment.

  Baseline(week -1 to 0)and core phase(week 6)

Secondary Outcomes (8)

• The change from baseline in the daily average frequency of urgency episodes and the scores.

  Baseline and Week 2,6,12,14,18,24

• average frequency of UI episodes

  Baseline and Week 2,6,12,14,18,24

• volume per micturition

  Baseline and Week 2,6,12,14,18,24

• maximum cystometric capacity (MCC)

  Baseline(week -1 to 0)and core phase(week 6)

• maximum detrusor pressure during first involuntary detrusor contraction (PdetmaxIDC)

  Baseline(week -1 to 0)and core phase(week 6)

Study Arms (2)

Botulinum Toxin Type A for Injection

ACTIVE COMPARATOR

Botulinum Toxin Type A is a specific formulation of a locally injected muscle relaxant whose active ingredient is botulinum toxin type A produced by clostridium botulinum A strain Hall. Excipients contain sucrose,dextran and gelatin.

Drug: Botulinum Toxin Type A for Injection

Placebo

PLACEBO COMPARATOR

The placebo does not include botulinum toxin A ,but include sucrose,dextran and gelatin.

Drug: Placebo

Interventions

Botulinum Toxin Type A for Injection DRUG

In these studies,patients received a minimum intramuscular(IM) dose of 100U of Botulinum Toxin Type A administered to 20 injection sites

Also known as: HengLi®

Botulinum Toxin Type A for Injection

Placebo DRUG

In these studies,patients received placebo administered to 20 injection sites

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients should provided written informed consent.
• Patients with idiopathic or neurogenic overactive bladder with symptoms of episodes of urgency, incontinence, micturition and nocturia,( maintaining spontaneous voiding ).
• Patients must experienced 3 or more urgency UI episodes in a 3-day period and an average of 8 or moremicturitions per day.
• Patients were inadequately treated with prior anticholinergic therapy due to inadequate efficacy or intolerable side effects.
• Anticholinergic use was not permitted within 7 days of screening or patients treated with anticholinergics at baseline continued at a stable dose throughout the study.

You may not qualify if:

• Patients with difficulty urinating have a PVR of 50 ml or more.
• Patients requiring indwelling catheter or clean intermittent catheterization (CIC).
• Female patients who is pregnant, lactating, or with child-bearing potential without contraception.
• People who are allergic to study drugs or its ingredients or allergic should be excluded.
• Current severe cardiovascular disease ongoing clinical instability.
• Renal insufficiency and serum creatinine greater than 1.5 times the upper limit of normal.
• Liver diseases, ALT or AST greater than 2 times the upper limit of normal.
• Alcohol or drug abusers.
• Have participated in the clinical trials of other drugs within a month.
• Any previous botulinum toxin therapy for a urologic condition within 6 months.
• Urinary tract infection (① patients with symptoms of fever, pyuria, urinary frequency, urgency or dysuria etc.; ② positive urine culture ( bacterial colony counts \> 10\^5 cfu/ml) or urine WBC\> 10/ HPF; meet both of ① and ② or any one can be diagnosed as a urinary tract infection).
• Patients accompany of bladder stones, ureteral stones or urethral; or lithotripsy performed within 3 months.
• Patients of bladder or prostate cancer.
• Patients with diabetes.
• Patients with aminoglycoside antibiotics or neuromuscular junction function drugs within one week.

Sponsors & Collaborators

• Lanzhou Institute of Biological Products Co., Ltd: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A; Injections; Hengli BTX-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; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: June 1, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2019
• Last Updated: January 3, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share