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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Botulinum Toxin Type A for Injection
In these studies,patients received a minimum intramuscular(IM) dose of 100U of Botulinum Toxin Type A administered to 20 injection sites
Other Names:
  • HengLi®
PLACEBO_COMPARATOR: Placebo
The placebo does not include botulinum toxin A ,but include sucrose,dextran and gelatin.
Drug: Placebo
In these studies,patients received placebo administered to 20 injection sites

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lanzhou Institute of Biological Products Co., Ltd

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Overactive Bladder

Clinical Trials on Botulinum Toxin Type A for Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings