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

Primary Purpose

Overactive Bladder

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Botulinum Toxin Type A for Injection
Placebo
Sponsored by
Lanzhou Institute of Biological Products Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring overactive bladder, Botulinum Toxin Type A for Injection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. All patients should provided written informed consent.
  2. Patients with idiopathic or neurogenic overactive bladder with symptoms of episodes of urgency, incontinence, micturition and nocturia,( maintaining spontaneous voiding ).
  3. Patients must experienced 3 or more urgency UI episodes in a 3-day period and an average of 8 or moremicturitions per day.
  4. Patients were inadequately treated with prior anticholinergic therapy due to inadequate efficacy or intolerable side effects.
  5. 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:

  1. Patients with difficulty urinating have a PVR of 50 ml or more.
  2. Patients requiring indwelling catheter or clean intermittent catheterization (CIC).
  3. Female patients who is pregnant, lactating, or with child-bearing potential without contraception.
  4. People who are allergic to study drugs or its ingredients or allergic should be excluded.
  5. Current severe cardiovascular disease ongoing clinical instability.
  6. Renal insufficiency and serum creatinine greater than 1.5 times the upper limit of normal.
  7. Liver diseases, ALT or AST greater than 2 times the upper limit of normal.
  8. Alcohol or drug abusers.
  9. Have participated in the clinical trials of other drugs within a month.
  10. Any previous botulinum toxin therapy for a urologic condition within 6 months.
  11. 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).
  12. Patients accompany of bladder stones, ureteral stones or urethral; or lithotripsy performed within 3 months.
  13. Patients of bladder or prostate cancer.
  14. Patients with diabetes.
  15. Patients with aminoglycoside antibiotics or neuromuscular junction function drugs within one week.
  16. Any medical condition that may lead the subject to increased risk with exposure to Botulinum Toxin Type A, including myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other disorder that might have interfered with neuromuscular function.
  17. Patients with bleeding tendency.
  18. Patients have used anticoagulant agents within one week before the first use of study drug.
  19. Investigator's opinion that the subject has a concurrent condition(s) that may put the subject at significant risk, may confound the study results, or may interfere significantly with the conduct of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Botulinum Toxin Type A for Injection

    Placebo

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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)
    average frequency of UI episodes
    The change from baseline in the daily average frequency of UI episodes
    volume per micturition
    The change from baseline in volume voided per micturition
    maximum cystometric capacity (MCC)
    The change from baseline in MCC at week 6 after the first treatment ( Only in patients with neurogenic overactive bladder )
    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 )
    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 )
    The change from baseline in the QOL score
    The change from baseline in the QOL score
    The change from baseline in the OABSS total summary score
    The change from baseline in the OABSS total summary score

    Full Information

    First Posted
    May 17, 2016
    Last Updated
    January 2, 2018
    Sponsor
    Lanzhou Institute of Biological Products Co., Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02786407
    Brief Title
    A Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A in Patients With Overactive Bladder (OAB)
    Official Title
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    November 2018 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lanzhou Institute of Biological Products Co., Ltd

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overactive Bladder
    Keywords
    overactive bladder, Botulinum Toxin Type A for Injection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    216 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Botulinum Toxin Type A for Injection
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    The placebo does not include botulinum toxin A ,but include sucrose,dextran and gelatin.
    Intervention Type
    Drug
    Intervention Name(s)
    Botulinum Toxin Type A for Injection
    Other Intervention Name(s)
    HengLi®
    Intervention Description
    In these studies,patients received a minimum intramuscular(IM) dose of 100U of Botulinum Toxin Type A administered to 20 injection sites
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    In these studies,patients received placebo administered to 20 injection sites
    Primary Outcome Measure Information:
    Title
    average frequency of micturition
    Description
    The primary efficacy variables is the change from baseline in the daily average frequency of micturition at week 6 after the first treatment.
    Time Frame
    Baseline(week -1 to 0)and core phase(week 6)
    Secondary Outcome Measure Information:
    Title
    The change from baseline in the daily average frequency of urgency episodes and the scores.
    Description
    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)
    Time Frame
    Baseline and Week 2,6,12,14,18,24
    Title
    average frequency of UI episodes
    Description
    The change from baseline in the daily average frequency of UI episodes
    Time Frame
    Baseline and Week 2,6,12,14,18,24
    Title
    volume per micturition
    Description
    The change from baseline in volume voided per micturition
    Time Frame
    Baseline and Week 2,6,12,14,18,24
    Title
    maximum cystometric capacity (MCC)
    Description
    The change from baseline in MCC at week 6 after the first treatment ( Only in patients with neurogenic overactive bladder )
    Time Frame
    Baseline(week -1 to 0)and core phase(week 6)
    Title
    maximum detrusor pressure during first involuntary detrusor contraction (PdetmaxIDC)
    Description
    The change from baseline in PdetmaxIDC at week 6 after the first treatment ( Only in patients with neurogenic overactive bladder )
    Time Frame
    Baseline(week -1 to 0)and core phase(week 6)
    Title
    volume at first IDC (VPmaxIDC)
    Description
    The change from baseline in VPmaxIDC at week 6 after the first treatment ( Only in patients with neurogenic overactive bladder )
    Time Frame
    Baseline(week -1 to 0)and core phase(week 6)
    Title
    The change from baseline in the QOL score
    Description
    The change from baseline in the QOL score
    Time Frame
    Baseline and Week 2,6,12,14,18,24
    Title
    The change from baseline in the OABSS total summary score
    Description
    The change from baseline in the OABSS total summary score
    Time Frame
    Baseline and Week 2,6,12,14,18,24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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. 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. Any medical condition that may lead the subject to increased risk with exposure to Botulinum Toxin Type A, including myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other disorder that might have interfered with neuromuscular function. Patients with bleeding tendency. Patients have used anticoagulant agents within one week before the first use of study drug. Investigator's opinion that the subject has a concurrent condition(s) that may put the subject at significant risk, may confound the study results, or may interfere significantly with the conduct of the study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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