Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder
Summary
Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit
Timeline
- Start
- 2008-01
- Primary completion
- 2009-02
- Completion
- 2009-02
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs Tamsulosin - Low Dose Level; p = 0.5388; Odds Ratio (OR) 1.38 (95% CI 0.50 to 3.80); Regression, Logistic NCT00796614 ↗
registry analysis (superiority or other test); Placebo vs Tamsulosin - Medium Dose Level; p = 0.3430; Odds Ratio (OR) 0.59 (95% CI 0.20 to 1.76); Regression, Logistic NCT00796614 ↗
registry analysis (superiority or other test); Placebo vs Tamsulosin - High Dose Level; p = 0.5209; Odds Ratio (OR) 1.41 (95% CI 0.50 to 3.97); Regression, Logistic NCT00796614 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tamsulosin | Other / unclassified | 0.001 mg/kg | Oral |
| Subject | Tamsulosin | Other / unclassified | 0.002 mg/kg | Oral |
| Subject | Tamsulosin | Other / unclassified | 0.004 mg/kg | Oral |
| Subject | Tamsulosin | Other / unclassified | 0.008 mg/kg | Oral |