Status:
COMPLETED
Dose-Escalating Study of Propiverine Hydrochloride in Children Suffering From Overactive Bladder
Lead Sponsor:
APOGEPHA Arzneimittel GmbH
Conditions:
Overactive Bladder
Eligibility:
All Genders
5-10 years
Phase:
PHASE2
Brief 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 sufferi...
Eligibility Criteria
Inclusion
- Main
- Micturition Frequency ≥6 micturitions during awake period
- Urge Incontinence Episodes ≥1/week
- Urgency Episodes ≥1/day
- Main
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00795925
Start Date
October 1 2004
End Date
December 1 2005
Last Update
November 21 2008
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