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Dose-Escalating Study of Propiverine Hydrochloride in Children Suffering From Overactive Bladder

NCT ID: NCT00795925

Last Updated: 2008-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overactive Bladder

Keywords

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propiverine anticholinergics urinary incontinence overactive bladder children dose-finding in children aged 5-10 years

Study Design

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Blinding Strategy

NONE

Study Groups

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propiverine hydrochloride

Group Type EXPERIMENTAL

propiverine hydrochloride

Intervention Type DRUG

coated tablets containing 5 mg

consecutive dose escalation of 5 mg, 10 mg or 15 mg propiverine b.i.d.

Interventions

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propiverine hydrochloride

coated tablets containing 5 mg

consecutive dose escalation of 5 mg, 10 mg or 15 mg propiverine b.i.d.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Micturition Frequency ≥6 micturitions during awake period
* Urge Incontinence Episodes ≥1/week
* Urgency Episodes ≥1/day

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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APOGEPHA Arzneimittel GmbH

INDUSTRY

Sponsor Role lead

Principal Investigators

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Professor Ulla Sillen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Drottning Silvias ,Barn- och ungdomssjukhus, SU/Östra,416 85 Göteborg

References

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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.

Reference Type DERIVED
PMID: 20384395 (View on PubMed)

Other Identifiers

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APOGEPHA-8403030

Identifier Type: -

Identifier Source: org_study_id