PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder

NCT00340704 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2016-02-17

Study results available
· View outcomes & findings →

Summary

Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the course of 12 months of active treatment.

Conditions

  • Bladder, Neurogenic

Interventions

DRUG

tamsulosin hydrochloride

oral

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • Germany
  • India
  • Italy
  • Mexico
  • Philippines
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

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 NCT00340704 on ClinicalTrials.gov