Trials / Completed
CompletedNCT00795925
Dose-Escalating Study of Propiverine Hydrochloride in Children Suffering From Overactive Bladder
Dose-Escalating Study of Propiverine Hydrochloride (Mictonetten®) in Children Suffering From Frequency-Urgency-Syndrome and Urinary Incontinence Indicative of Detrusor Overactivity (Overactive Bladder)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- APOGEPHA Arzneimittel GmbH · Industry
- Sex
- All
- Age
- 5 Years – 10 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | propiverine hydrochloride | coated tablets containing 5 mg consecutive dose escalation of 5 mg, 10 mg or 15 mg propiverine b.i.d. |
Timeline
- Start date
- 2004-10-01
- Completion
- 2005-12-01
- First posted
- 2008-11-21
- Last updated
- 2008-11-21
Source: ClinicalTrials.gov record NCT00795925. Inclusion in this directory is not an endorsement.