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

NCT ID: NCT00340704

Last Updated: 2016-02-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder, Neurogenic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1. Low dose group

Group Type EXPERIMENTAL

tamsulosin hydrochloride

Intervention Type DRUG

oral

2. Medium dose group

Group Type EXPERIMENTAL

tamsulosin hydrochloride

Intervention Type DRUG

oral

3. High dose group

Group Type EXPERIMENTAL

tamsulosin hydrochloride

Intervention Type DRUG

oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tamsulosin hydrochloride

oral

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Neuropathic bladder secondary to known neurological disorder
* Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements at baseline

Exclusion Criteria

* Clinically significant abnormalities as determined by the investigator
* A history of relevant orthostatic hypotension, fainting spells or blackouts
Minimum Eligible Age

2 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Birmingham, Alabama, United States

Site Status

Los Angeles, California, United States

Site Status

Jacksonville, Florida, United States

Site Status

Tampa, Florida, United States

Site Status

Springfield, Illinois, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Shreveport, Louisiana, United States

Site Status

St Louis, Missouri, United States

Site Status

Buffalo, New York, United States

Site Status

Lake Success, New York, United States

Site Status

Tarrytown, New York, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Akron, Ohio, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Nashville, Tennessee, United States

Site Status

Dallas, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Madison, Wisconsin, United States

Site Status

Ghent, , Belgium

Site Status

Santo André, , Brazil

Site Status

São Paulo, , Brazil

Site Status

Halifax, , Canada

Site Status

Montreal, , Canada

Site Status

Montreal, , Canada

Site Status

Toronto, , Canada

Site Status

Berlin, , Germany

Site Status

Deggendorf, , Germany

Site Status

Essen, , Germany

Site Status

Hamburg, , Germany

Site Status

Mainz, , Germany

Site Status

Ahmedabad, , India

Site Status

Belagavi, , India

Site Status

Bengaluru, , India

Site Status

Hyderabaad, , India

Site Status

Kochi, , India

Site Status

Lucknow, , India

Site Status

Lucknow, , India

Site Status

Ludhiana, , India

Site Status

Ludhiana, , India

Site Status

Manipal, , India

Site Status

Mumbai, , India

Site Status

Nadiād, , India

Site Status

Nagpur, , India

Site Status

New Delhi, , India

Site Status

Pune, , India

Site Status

Pune, , India

Site Status

Cagliari, , Italy

Site Status

Florence, , Italy

Site Status

Roma, , Italy

Site Status

León, , Mexico

Site Status

Puebla City, , Mexico

Site Status

Manila, , Philippines

Site Status

Pasig, , Philippines

Site Status

Quezon City, , Philippines

Site Status

Moscow, , Russia

Site Status

Saint Petersburg, , Russia

Site Status

Bloemfontein, , South Africa

Site Status

Cape Town, , South Africa

Site Status

Johannesburg, , South Africa

Site Status

Pretoria, , South Africa

Site Status

Roodepoort, , South Africa

Site Status

Gwangju, , South Korea

Site Status

Incheon, , South Korea

Site Status

Pusan, , South Korea

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Seoul, , South Korea

Site Status

Barcelona, , Spain

Site Status

Madrid, , Spain

Site Status

Málaga, , Spain

Site Status

Chernivtsy, , Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

527.66

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.