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

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.

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Detailed Description

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Conditions

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Overactive Bladder

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