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

NCT00795925 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2008-11-21

No results posted yet for this study

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) for determination of the recommended dose in children.

Conditions

Interventions

DRUG

propiverine hydrochloride

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

Sponsors & Collaborators

  • APOGEPHA Arzneimittel GmbH

    lead INDUSTRY

Principal Investigators

  • Professor Ulla Sillen, M.D. · Drottning Silvias ,Barn- och ungdomssjukhus, SU/Östra,416 85 Göteborg

Study Design

Masking
NONE

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Completion
2005-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00795925 on ClinicalTrials.gov