- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02786407
A Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A in Patients With Overactive Bladder (OAB)
January 2, 2018 updated by: Lanzhou Institute of Biological Products Co., Ltd
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)
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Anticipated)
216
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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.
|
In these studies,patients received a minimum intramuscular(IM) dose of 100U of Botulinum Toxin Type A administered to 20 injection sites
Other Names:
|
PLACEBO_COMPARATOR: Placebo
The placebo does not include botulinum toxin A ,but include sucrose,dextran and gelatin.
|
In these studies,patients received placebo administered to 20 injection sites
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline(week -1 to 0)and core phase(week 6)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change from baseline in the daily average frequency of urgency episodes and the scores.
Time Frame: Baseline and Week 2,6,12,14,18,24
|
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
|
average frequency of UI episodes
Time Frame: Baseline and Week 2,6,12,14,18,24
|
The change from baseline in the daily average frequency of UI episodes
|
Baseline and Week 2,6,12,14,18,24
|
volume per micturition
Time Frame: Baseline and Week 2,6,12,14,18,24
|
The change from baseline in volume voided per micturition
|
Baseline and Week 2,6,12,14,18,24
|
maximum cystometric capacity (MCC)
Time Frame: Baseline(week -1 to 0)and core phase(week 6)
|
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)
Time Frame: Baseline(week -1 to 0)and core phase(week 6)
|
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)
Time Frame: Baseline(week -1 to 0)and core phase(week 6)
|
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
Time Frame: Baseline and Week 2,6,12,14,18,24
|
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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (ANTICIPATED)
November 1, 2018
Study Completion (ANTICIPATED)
December 1, 2019
Study Registration Dates
First Submitted
May 17, 2016
First Submitted That Met QC Criteria
May 25, 2016
First Posted (ESTIMATE)
June 1, 2016
Study Record Updates
Last Update Posted (ACTUAL)
January 3, 2018
Last Update Submitted That Met QC Criteria
January 2, 2018
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- HengLi004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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