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This is a multicenter, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of Botulinus Toxin Type A for Injection (HengLiĀ®) 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 (HengLiĀ®) 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).
Eligible patients will be randomized on day 1 to receive double-blind treatment with Botulinus Toxin Type A for Injection (HengLiĀ®) 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 (HengLiĀ®) or placebo at day 0 (visit 0).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | The placebo does not include botulinum toxin A ,but include sucrose,dextran and gelatin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in the daily average frequency of urgency episodes and the scores. | The degree of urgency is divided into 5 grades (With 0 points representing no hurry, hurry on behalf of 5 points, 1~5 points gradually increase depending on the degree of urgency) | Baseline and Week 2,6,12,14,18,24 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D007267 | Injections |
| C000595968 | Hengli BTX-A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| Placebo | Drug | In these studies,patients received placebo administered to 20 injection sites |
|
| average frequency of UI episodes |
The change from baseline in the daily average frequency of UI episodes |
| Baseline and Week 2,6,12,14,18,24 |
| volume per micturition | The change from baseline in volume voided per micturition | Baseline and Week 2,6,12,14,18,24 |
| maximum cystometric capacity (MCC) | The change from baseline in MCC at week 6 after the first treatment ( Only in patients with neurogenic overactive bladder ) | Baseline(week -1 to 0)and core phase(week 6) |
| maximum detrusor pressure during first involuntary detrusor contraction (PdetmaxIDC) | The change from baseline in PdetmaxIDC at week 6 after the first treatment ( Only in patients with neurogenic overactive bladder ) | Baseline(week -1 to 0)and core phase(week 6) |
| volume at first IDC (VPmaxIDC) | The change from baseline in VPmaxIDC at week 6 after the first treatment ( Only in patients with neurogenic overactive bladder ) | Baseline(week -1 to 0)and core phase(week 6) |
| The change from baseline in the QOL score | 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 | The change from baseline in the OABSS total summary score | Baseline and Week 2,6,12,14,18,24 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |