NCT02786407

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

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection in Chinese Subjects With Overactive Bladder (OAB)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Lanzhou Institute of Biological Products Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Eligible patients will be randomized on day 1 to receive double-blind treatment with Botulinus Toxin Type A for Injection (HengLi®) 100U or placebo in a 2:1 ratio. A total of 216 subjects will be randomized into this study. Followup visits will occur at day 0, week 6 and 12, and week 14, 18 and 24 thereafter until study exit at week 24 unless re-treatment was necessary. The primary efficacy variables is the change from baseline in the daily average frequency of micturition at week 6. After a screening period of 1 week, all eligible patients will be randomized to receive a single intramuscular treatment with Botulinus Toxin Type A for Injection (HengLi®) or placebo at day 0 (visit 0).

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A for Injection	In these studies,patients received a minimum intramuscular(IM) dose of 100U of Botulinum Toxin Type A administered to 20 injection sites
DRUG	Placebo	In these studies,patients received placebo administered to 20 injection sites

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-11-01
• Completion: 2019-12-01
• First posted: 2016-06-01
• Last updated: 2018-01-03