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)
Overview
- Phase
- Phase 3
- Intervention
- Botulinum Toxin Type A for Injection
- Conditions
- Overactive Bladder
- Sponsor
- Lanzhou Institute of Biological Products Co., Ltd
- Enrollment
- 216
- Primary Endpoint
- average frequency of micturition
- Last Updated
- 8 years ago
Overview
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).
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Botulinum Toxin Type A for Injection
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.
Intervention: Botulinum Toxin Type A for Injection
Placebo
The placebo does not include botulinum toxin A ,but include sucrose,dextran and gelatin.
Intervention: Placebo
Outcomes
Primary Outcomes
average frequency of micturition
Time Frame: Baseline(week -1 to 0)and core phase(week 6)
The primary efficacy variables is the change from baseline in the daily average frequency of micturition at week 6 after the first treatment.
Secondary Outcomes
- 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)
- maximum detrusor pressure during first involuntary detrusor contraction (PdetmaxIDC)(Baseline(week -1 to 0)and core phase(week 6))
- 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))
- volume at first IDC (VPmaxIDC)(Baseline(week -1 to 0)and core phase(week 6))
- The change from baseline in the QOL score(Baseline and Week 2,6,12,14,18,24)
- The change from baseline in the OABSS total summary score(Baseline and Week 2,6,12,14,18,24)