Overactive BladderPhase 2NCT00795925
Dose-Escalating Study of Propiverine Hydrochloride in Children Suffering From Overactive Bladder
A Phase 2 study testing propiverine hydrochloride in people with Overactive Bladder, run by APOGEPHA Arzneimittel GmbH.
Trial summary
The open-label dose-escalating two-centre study was designed to assess the pharmacokinetics as well as safety, tolerability and efficacy parameters of propiverine in patients 5-10 years of age suffering from frequency-urgency-syndrome and urinary incontinence indicative of detrusor overactivity (overactive bladder)… Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- propiverine hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Dec 2005
- Phase
- Phase 2
- 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
Main Inclusion Criteria:
- Micturition Frequency ≥6 micturitions during awake period
- Urge Incontinence Episodes ≥1/week
- Urgency Episodes ≥1/day
Main Exclusion Criteria:
- Contraindication to anticholinergic therapy
- Repeated measurement of Post Void Residual ≥20 mL
- Nocturnal Enuresis
- Clinically significant cardiovascular, hepatic, renal, gastrointestinal or hematological disease, psychiatric disorder or diabetes insipidus
- Anatomical abnormalities of the urinary tract
About this study
Official title: Dose-Escalating Study of Propiverine Hydrochloride (Mictonetten®) in Children Suffering From Frequency-Urgency-Syndrome and Urinary Incontinence Indicative of Detrusor Overactivity (Overactive Bladder)
The open-label dose-escalating two-centre study was designed to assess the pharmacokinetics as well as safety, tolerability and efficacy parameters of propiverine in patients 5-10 years of age suffering from frequency-urgency-syndrome and urinary incontinence indicative of detrusor overactivity (overactive bladder) for determination of the recommended dose in children.
- Conditions
- Overactive Bladder
- Being tested
- propiverine hydrochloride
- Keywords
- propiverine, anticholinergics, urinary incontinence, overactive bladder, children, dose-finding in children aged 5-10 years
- 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.
propiverine hydrochlorideDrug
coated tablets containing 5 mg
consecutive dose escalation of 5 mg, 10 mg or 15 mg propiverine b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| propiverine hydrochloride | Experimental | Not described Receives: Drug: propiverine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of propiverine and its main metabolite propiverine N-oxide at steady state: Ctrough, Cmax, Tmax, AUC0-8h. Children were separated into 3 groups.
Secondary outcomes (1)
Tolerability of propiverine. Efficacy: Changes from baseline: voiding frequency, incontinence and urgency episodes,voided volume. Safety: Post Void Residual (PVR),adverse events,laboratory values (urine, blood), ECG.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startOct 2004
- Study completionDec 2005
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 2
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- APOGEPHA Arzneimittel GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Professor Ulla Sillen, M.D., Principal investigator, Drottning Silvias ,Barn- och ungdomssjukhus, SU/Östra,416 85 Göteborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795925
- Sponsor's protocol ID
- APOGEPHA-8403030
- Status last verified
- Nov 2008
- First submitted
- 13 Nov 2008
- Last updated
- 21 Nov 2008
- Results posted
- No
Publications
Siegmund W, Sillen U, Lackgren G, Schnabel F, Murtz G, Feustel C. Pharmacokinetics and pharmacodynamics of propiverine in children aged between 5 and 10 years with symptoms of overactive bladder. Clin Pharmacokinet. 2010 May;49(5):335-42. doi: 10.2165/11319990-000000000-00000.
PubMed 20384395
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Escalating Study of Propiverine Hydrochloride (Mictonetten®) in Children Suffering From Frequency-Urgency-Syndrome and Urinary Incontinence Indicative of Detrusor Overactivity (Overactive Bladder)
- ClinicalTrials.gov ID
- NCT00795925
- Acronym / sponsor ID
- APOGEPHA-8403030
- Conditions
- Overactive Bladder
- Keywords
- propiverine, anticholinergics, urinary incontinence, overactive bladder, children, dose-finding in children aged 5-10 years
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- APOGEPHA Arzneimittel GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Study completion
- Dec 2005 (actual)
- First posted
- 21 Nov 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 open-label dose-escalating two-centre study was designed to assess the pharmacokinetics as well as safety, tolerability and efficacy parameters of propiverine in patients 5-10 years of age suffering from frequency-urgency-syndrome and urinary incontinence indicative of detrusor overactivity (overactive bladder) for determination of the recommended dose in children.
Study design
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| propiverine hydrochloride | Experimental | Drug: propiverine hydrochloride |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 hydrochloridecoated tablets containing 5 mg consecutive dose escalation of 5 mg, 10 mg or 15 mg propiverine b.i.d. | Drug | propiverine hydrochloride |
Primary outcome
Pharmacokinetic parameters of propiverine and its main metabolite propiverine N-oxide at steady state: Ctrough, Cmax, Tmax, AUC0-8h. Children were separated into 3 groups.
1 secondary outcome
Tolerability of propiverine. Efficacy: Changes from baseline: voiding frequency, incontinence and urgency episodes,voided volume. Safety: Post Void Residual (PVR),adverse events,laboratory values (urine, blood), ECG.
Time frame: two weeks
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 21 Nov 2008.
- Derived from this study: PubMed 20384395Siegmund W, Sillen U, Lackgren G, Schnabel F, Murtz G, Feustel C. Pharmacokinetics and pharmacodynamics of propiverine in children aged between 5 and 10 years with symptoms of overactive bladder. Clin Pharmacokinet. 2010 May;49(5):335-42. doi: 10.2165/11319990-000000000-00000.
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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.
Professor Ulla Sillen, M.D. principal investigator
Drottning Silvias ,Barn- och ungdomssjukhus, SU/Östra,416 85 Göteborg
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing propiverine hydrochloride in people with Overactive Bladder, 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?
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 21 Nov 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Pharmacokinetic parameters of propiverine and its main metabolite propiverine N-oxide at steady state: Ctrough, Cmax, Tmax, AUC0-8h. Children were separated into 3 groups.. 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 NCT00795925, 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 21 Nov 2008.