Overactive BladderPhase 3NCT01512004
Propiverine Hydrochloride Extended-Release Capsule for Overactive Bladder
A Phase 3 study testing Propiverine Hydrochloride and Tolterodine Extended-release Tablet in people with Overactive Bladder, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Propiverine Hydrochloride and Tolterodine Extended-release Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Aug 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65, male or female patient has a diagnosis of overactive bladder and the symptoms of OAB>3 months subject has urinary frequency (average micturition frequency within 24h>8 times), urgency and/or urge incontinence by micturition diary card during screening period
- Mean volume of single micturition is less than 200ml by micturition diary dard during screening period
- The subject is willing and able to complete the micturition diary card correctly
- Subject's urine routine test show that he/she has no urinary tract infection Subject signs informed consent form
Who cannot join
- Confirmed by the investigator that subject has severe stress incontinence.
- Subject who has serious heart disease or arrhythmia, in the investigator's opinion, is not suitable to enroll.
- Subject who has contraindications of anticholinergic therapy, such as urinary retention, gastric retention and uncontrollable angle closure glaucoma.
- Subject who has a symptomatic acute urinary tract infection.
- Subject who has a recurrent urinary tract infection.
- Subject who has interstitial cystitis.
Show all 13Show fewer
- Subject who has an agnogenic hematuria.
- Subject who has a bladder outlet obstruction of clinical significance.
- Subject who needs retention catheterization or intermittent catheterization.
- Patient with malignant tumor.
- Subject who has received anticholinergic drugs or other drugs for treating OAB within washout period, or who will receive these drugs after this study begins.
- Subject who is pregnant or lactating, or plans to be pregnant subject who has received other clinical study drugs or its participating in other clinical trial within 30 days.
- Women of childbearing age who has not taken sufficient contraception measures within 3 months before random number distribution; or intends to stop the contraception measures during the trial or within one month after the treatment is over.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study of Propiverine Hydrochloride Extended-Release Capsule in the Treatment of Overactive Bladder (OAB) in Chinese Population With Urgent Micturition, Frequent Micturition and/or Urge Urinary Incontinence
The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.
Read the detailed description
This is a multi-center, randomized, doubled-blind, double dummy clinical study, in comparison with Tolterodine Tartrate Extended-Release Tablet as active parallel control to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of Overactive Bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.
- Conditions
- Overactive Bladder
- Being tested
- Propiverine Hydrochloride, Tolterodine Extended-release Tablet
- Keywords
- Overactive Bladder, urgent micturition, frequent micturition, urge urinary incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propiverine HydrochlorideDrug
Also called Mictonorm, Propierine Hydrochloride Extended-Release Capsule
drug of oral capsule
Tolterodine Extended-release TabletDrug
4mg/tablet; oral; once per day
| Study group | Role | What they receive |
|---|---|---|
| Propiverine Hydrochloride Extended-Release Capsule | Active comparator | 30 mg/capsule; oral; once per day Receives: Drug: Propiverine Hydrochloride |
| Tolterodine Extended-release Tablet | Placebo comparator | 4mg/tablet; oral; once per day Receives: Drug: Tolterodine Extended-release Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record
The voiding frequency per 24 hours, and the alteration of mean micturition frequency within 24 hours on the basis of continuous 3-day record, prior to medication and 8 weeks after medication
Measured: prior to medication and 8 weeks after medication
Secondary outcomes (1)
The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record
The alteration of mean incontinence frequency, mean micturition frequency and volume within 24 hous on the basis of continuous 3-day record,prior to medication, 2 weeks and 8 weeks after medication. Additionaly, to evaluate the subject's feeling of treatment benefit and the time of the drug effect onset.
Measured: prior to medication, 2 weeks and 8 weeks after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2010
- Study completionAug 2011
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- APOGEPHA Arzneimittel GmbH
- Responsible party
- Sponsor
- Investigators
- Benjamin Li, PhD, Study director, Lee's Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512004
- Sponsor's protocol ID
- LEES-MIC
- Status last verified
- Jan 2012
- First submitted
- 24 Nov 2010
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Propiverine Hydrochloride Extended-Release Capsule in the Treatment of Overactive Bladder (OAB) in Chinese Population With Urgent Micturition, Frequent Micturition and/or Urge Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01512004
- Acronym / sponsor ID
- LEES-MIC
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder, urgent micturition, frequent micturition, urge urinary incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- APOGEPHA Arzneimittel GmbH
- Study start
- Jan 2010
- Primary completion
- Jan 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Jan 2012 (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.
The purpose of this Phase III study is to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of overactive bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.
Detailed description
This is a multi-center, randomized, doubled-blind, double dummy clinical study, in comparison with Tolterodine Tartrate Extended-Release Tablet as active parallel control to evaluate the efficacy and safety of Propiverine Hydrochloride Extended-Release Capsule in the treatment of Overactive Bladder in Chinese population with urgent micturition, frequent micturition and/or urge urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propiverine Hydrochloride Extended-Release Capsule | Active comparator | Drug: Propiverine Hydrochloride30 mg/capsule; oral; once per day |
| Tolterodine Extended-release Tablet | Placebo comparator | Drug: Tolterodine Extended-release Tablet4mg/tablet; oral; once per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 65, male or female patient has a diagnosis of overactive bladder and the symptoms of OAB>3 months subject has urinary frequency (average micturition frequency within 24h>8 times), urgency and/or urge incontinence by micturition diary card during screening period
- Mean volume of single micturition is less than 200ml by micturition diary dard during screening period
- The subject is willing and able to complete the micturition diary card correctly
- Subject's urine routine test show that he/she has no urinary tract infection Subject signs informed consent form
Key exclusion criteria (13 listed)
- Confirmed by the investigator that subject has severe stress incontinence.
- Subject who has serious heart disease or arrhythmia, in the investigator's opinion, is not suitable to enroll.
- Subject who has contraindications of anticholinergic therapy, such as urinary retention, gastric retention and uncontrollable angle closure glaucoma.
- Subject who has a symptomatic acute urinary tract infection.
- Subject who has a recurrent urinary tract infection.
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 |
|---|---|---|
| Propiverine HydrochlorideAlso: Mictonorm, Propierine Hydrochloride Extended-Release Capsuledrug of oral capsule | Drug | Propiverine Hydrochloride Extended-Release Capsule |
| Tolterodine Extended-release Tablet4mg/tablet; oral; once per day | Drug | Tolterodine Extended-release Tablet |
Primary outcome
Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record
Time frame: prior to medication and 8 weeks after medication
The voiding frequency per 24 hours, and the alteration of mean micturition frequency within 24 hours on the basis of continuous 3-day record, prior to medication and 8 weeks after medication
1 secondary outcome
The alteration of mean incontinence frequency and mean micturition frequency and volume within 24 hours on the basis of continuous 3-day record
Time frame: prior to medication, 2 weeks and 8 weeks after medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
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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.
Benjamin Li, PhD study director
Lee's Pharmaceutical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propiverine Hydrochloride and Tolterodine Extended-release Tablet in people with Overactive Bladder, run by Lee's Pharmaceutical Limited at 1 site in China.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 25 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Alteration of mean micturition frequency within 24h on the basis of continuous 3-day record (time frame: prior to medication and 8 weeks after medication). 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 25 Jan 2012; AzTrials last refreshed its copy on 27 Oct 2026.