Overactive BladderPhase 3NCT00603343
Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence
A Phase 3 study testing Mictonetten 5 mg, coated tablet in people with Overactive Bladder and Urinary Incontinence, run by APOGEPHA Arzneimittel GmbH.
Trial summary
The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic overactive bladder and urinary incontinence. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Overactive Bladder, Urinary Incontinence, Children
- What is being tested?
- Mictonetten 5 mg, coated tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Dec 2006
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- voiding frequency 8 or above per day
- at least one incontinence episode per day
- age between 5-10 years
- body weight between 17 and 45 kg
Who cannot join
- normal age expected bladder capacity
- PVR more than 10 ml
- dysfunctional voiding
- neurogenic disorders
- UTI, constipation
About this study
Official title: Treatment With Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence: Results of a Randomized Placebo-Controlled Phase III Clinical Trial
The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic overactive bladder and urinary incontinence.
Read the detailed description
This clinical trial showed superior efficacy of propiverine over placebo and convincing tolerability for the treatment of children suffering from OAB and urinary incontinence.
- Conditions
- Overactive Bladder, Urinary Incontinence, Children
- Being tested
- Mictonetten 5 mg, coated tablet, placebo
- Keywords
- antimuscarinics, children, overactive bladder, propiverine, urinary incontinence, urotherapy
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mictonetten 5 mg, coated tabletDrug
Also called Mictonetten
propiverine 10 mg b.i.d. (17-27.9 kg BW) or propiverine 15 mg b.i.d. (28-45.0 kg BW)
placeboDrug
placebo corresponding to body weight
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Mictonetten 5 mg, coated tablet |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
voiding frequency
Measured: before therapy and at end of therapy
Secondary outcomes (3)
voided volume
Measured: before and at end of treatment
incontinence episodes per day
Measured: before and at end of therapy
safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate
Measured: before and at end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startJun 2004
- Primary completionSep 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- APOGEPHA Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniela Marschall-Kehrel, MD, Principal investigator, urologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603343
- Sponsor's protocol ID
- EudraCT-Number 200400124330
- Status last verified
- Jan 2008
- First submitted
- 16 Jan 2008
- Last updated
- 29 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marschall-Kehrel D, Feustel C, Persson de Geeter C, Stehr M, Radmayr C, Sillen U, Strugala G. Treatment with propiverine in children suffering from nonneurogenic overactive bladder and urinary incontinence: results of a randomized placebo-controlled phase 3 clinical trial. Eur Urol. 2009 Mar;55(3):729-36. doi: 10.1016/j.eururo.2008.04.062. Epub 2008 May 7.
PubMed 18502028
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence: Results of a Randomized Placebo-Controlled Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT00603343
- Acronym / sponsor ID
- EudraCT-Number 200400124330
- Conditions
- Overactive Bladder, Urinary Incontinence, Children
- Keywords
- antimuscarinics, children, overactive bladder, propiverine, urinary incontinence, urotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- APOGEPHA Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 29 Jan 2008 (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 study was conducted between 2004 and 2006 to prove efficacy and tolerability of the antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic overactive bladder and urinary incontinence.
Detailed description
This clinical trial showed superior efficacy of propiverine over placebo and convincing tolerability for the treatment of children suffering from OAB and urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Mictonetten 5 mg, coated tablet |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- voiding frequency 8 or above per day
- at least one incontinence episode per day
- age between 5-10 years
- body weight between 17 and 45 kg
Key exclusion criteria (5 listed)
- normal age expected bladder capacity
- PVR more than 10 ml
- dysfunctional voiding
- neurogenic disorders
- UTI, constipation
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 |
|---|---|---|
| Mictonetten 5 mg, coated tabletAlso: Mictonettenpropiverine 10 mg b.i.d. (17-27.9 kg BW) or propiverine 15 mg b.i.d. (28-45.0 kg BW) | Drug | 1 |
| placeboplacebo corresponding to body weight | Drug | 2 |
Primary outcome
voiding frequency
Time frame: before therapy and at end of therapy
3 secondary outcomes
voided volume
Time frame: before and at end of treatment
incontinence episodes per day
Time frame: before and at end of therapy
safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate
Time frame: before and at end of treatment
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 29 Jan 2008.
- Derived from this study: PubMed 18502028Marschall-Kehrel D, Feustel C, Persson de Geeter C, Stehr M, Radmayr C, Sillen U, Strugala G. Treatment with propiverine in children suffering from nonneurogenic overactive bladder and urinary incontinence: results of a randomized placebo-controlled phase 3 clinical trial. Eur Urol. 2009 Mar;55(3):729-36. doi: 10.1016/j.eururo.2008.04.062. Epub 2008 May 7.
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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.
Daniela Marschall-Kehrel, MD principal investigator
urologist
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mictonetten 5 mg, coated tablet in people with Overactive Bladder and Urinary Incontinence, run by APOGEPHA Arzneimittel GmbH.
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 5 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 29 Jan 2008. 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?
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?
voiding frequency (time frame: before therapy and at end of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00603343, which also lists 1 linked publication.
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 29 Jan 2008.