A Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A in Patients With Overactive Bladder (OAB)
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 3
Details
Lead Sponsor:
Lanzhou Institute of Biological Products Co., Ltd
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA