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NCT00340704 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Bladder, Neurogenic, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
143
Enrollment target
20
Study locations

NCT00340704: Completed Phase 2 study of Bladder, Neurogenic, sponsored by Boehringer Ingelheim.

NCT00340704 is a Phase 2 study of Bladder, Neurogenic that has completed, run by Boehringer Ingelheim. The registered enrollment target is 143 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00340704, a Phase 2 study of Bladder, Neurogenic, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
143 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Group D-Denovo: Leak point pressure (LPP) Response at(response defined as a subject who achieves an LPP pressure \<40 cm H2O) at the end of treatment based on two confirmatory values. Group D-527.51 Rollover: Leak point pressure (LPP) Response at (response defined as a subject who achieves an LPP pressure \<40 cm H2O) last value of the treatment based on two confirmatory values. The last value on treatment included any final value prior to discontinuation of treatment, regardless of the length o

Conditions Studied

Interventions

  • DRUG tamsulosin hydrochloride

Study Locations (20)

New York

  • - Buffalo
  • - Lake Success
  • - Tarrytown

Florida

  • - Jacksonville
  • - Tampa

Texas

  • - Dallas
  • - Houston

Alabama

  • - Birmingham

California

  • - Los Angeles

Illinois

  • - Springfield

Indiana

  • - Indianapolis

Louisiana

  • - Shreveport

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2006-04
Est. Completion 2009-06
Phase Phase 2
Boehringer Ingelheim

515 total trials

What the finished NCT00340704 record still lists

NCT00340704 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 1 condition, with Bladder, Neurogenic appearing as the primary indexed condition, and to 1 intervention - of which tamsulosin hydrochloride is the first listed.

NCT00340704 names 20 study sites across 16 states, led by New York, Florida, Texas.

Frequently Asked Questions

What is clinical trial NCT00340704 about?

NCT00340704 is a clinical study titled "PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder". 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.

What is the current status of trial NCT00340704?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 143 participants. The study started on 2006-04. Estimated completion is 2009-06.

What conditions does trial NCT00340704 study?

This clinical trial studies the following conditions: Bladder, Neurogenic.

What interventions are being tested in trial NCT00340704?

The interventions under investigation include: tamsulosin hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00340704?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00340704 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Bladder, Neurogenic

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00340704's enrollment target sits among peer trials

143 507th of 2000 higher than 1,494 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00340704, the US trial registry maintained by the National Library of Medicine. NCT00340704 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.