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Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder

NCT00796614 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2015-10-29

Study results available
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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

Conditions

  • Bladder, Neurogenic

Interventions

DRUG

tamsulosin hydrochloride

Oral

DRUG

Placebo

Oral

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00796614 on ClinicalTrials.gov