Overactive BladderPhase 3NCT02786407
A Study to Evaluate the Efficacy and Safety of Botulinum Toxin Type A in Patients With Overactive Bladder (OAB)
A Phase 3 study testing Botulinum Toxin Type A for Injection in people with Overactive Bladder, run by Lanzhou Institute of Biological Products Co., Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Botulinum Toxin Type A for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
About this study
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)
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).
Read the 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).
- Conditions
- Overactive Bladder
- Being tested
- Botulinum Toxin Type A for Injection, Placebo
- Keywords
- overactive bladder, Botulinum Toxin Type A for Injection
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A for InjectionDrug
Also called HengLi®
In these studies,patients received a minimum intramuscular(IM) dose of 100U of Botulinum Toxin Type A administered to 20 injection sites
PlaceboDrug
In these studies,patients received placebo administered to 20 injection sites
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Botulinum Toxin Type A for Injection |
| Placebo | Placebo comparator | The placebo does not include botulinum toxin A ,but include sucrose,dextran and gelatin. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline(week -1 to 0)and core phase(week 6)
Secondary outcomes (8)
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)
Measured: Baseline and Week 2,6,12,14,18,24
average frequency of UI episodes
The change from baseline in the daily average frequency of UI episodes
Measured: Baseline and Week 2,6,12,14,18,24
volume per micturition
The change from baseline in volume voided per micturition
Measured: 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 )
Measured: 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 )
Measured: 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 )
Measured: 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
Measured: 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
Measured: Baseline and Week 2,6,12,14,18,24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lanzhou Institute of Biological Products Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786407
- Sponsor's protocol ID
- HengLi004
- Status last verified
- Dec 2017
- First submitted
- 17 May 2016
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02786407
- Acronym / sponsor ID
- HengLi004
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, Botulinum Toxin Type A for Injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Lanzhou Institute of Biological Products Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A for Injection | Active comparator | Drug: Botulinum Toxin Type A for InjectionBotulinum 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 | Drug: PlaceboThe placebo does not include botulinum toxin A ,but include sucrose,dextran and gelatin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type A for InjectionAlso: HengLi®In these studies,patients received a minimum intramuscular(IM) dose of 100U of Botulinum Toxin Type A administered to 20 injection sites | Drug | Botulinum Toxin Type A for Injection |
| PlaceboIn these studies,patients received placebo administered to 20 injection sites | Drug | Placebo |
Primary outcome
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.
8 secondary outcomes
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
average frequency of UI episodes
Time frame: Baseline and Week 2,6,12,14,18,24
volume per micturition
Time frame: 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)
maximum detrusor pressure during first involuntary detrusor contraction (PdetmaxIDC)
Time frame: 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 the QOL score
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin Type A for Injection in people with Overactive Bladder, run by Lanzhou Institute of Biological Products Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average frequency of micturition (time frame: Baseline(week -1 to 0)and core phase(week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.