Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder
NCT ID: NCT00796614
Last Updated: 2015-10-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
231 participants
INTERVENTIONAL
2008-01-31
2009-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder
NCT00340704
Pharmacokinetics, Safety and Tolerability of Tamsulosin Hydrochloride in Children With Voiding Disorders
NCT02266524
Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction
NCT00549939
Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology
NCT00629720
Tamsulosin Phase III Clinical Trial -Double-Blind, Placebo Controlled Study in Male Patients With Lower Urinary Tract Syndrome
NCT00239317
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Participants received matching placebo to tamsulosin hydrochloride via opened capsules every day for 14 weeks
Placebo
Oral
Low dose
Participants received 0.001 - 0.002 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
tamsulosin hydrochloride
Oral
Medium dose
Participants received 0.002 - 0.004 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
tamsulosin hydrochloride
Oral
High dose
Participants received 0.004 - 0.008 mg/kg tamsulosin hydrochloride via opened capsules every day for 14 weeks
tamsulosin hydrochloride
Oral
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
tamsulosin hydrochloride
Oral
Placebo
Oral
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements
Exclusion Criteria
* A history of relevant orthostatic hypotension, fainting spells or blackouts
2 Years
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Los Angeles, California, United States
Tampa, Florida, United States
St Louis, Missouri, United States
Buffalo, New York, United States
Tarrytown, New York, United States
Winston-Salem, North Carolina, United States
Akron, Ohio, United States
Ghent, , Belgium
Santo André, , Brazil
São Paulo, , Brazil
Berlin, , Germany
Deggendorf, , Germany
Essen, , Germany
Hamburg, , Germany
Mainz, , Germany
Ahmedabad, , India
Belagavi, , India
Bengaluru, , India
Hyderabaad, , India
Kochi, , India
Lucknow, , India
Ludhiana, , India
Manipal, , India
Mumbai, , India
Nadiād, , India
Nagpur, , India
New Delhi, , India
Pune, , India
Pune, , India
Cagliari, , Italy
Florence, , Italy
Roma, , Italy
León, , Mexico
Puebla City, , Mexico
Manila, , Philippines
Pasig, , Philippines
Quezon City, , Philippines
Moscow, , Russia
Saint Petersburg, , Russia
Bloemfontein, , South Africa
Cape Town, , South Africa
Johannesburg, , South Africa
Pretoria, , South Africa
Roodepoort, , South Africa
Gwangju, , South Korea
Incheon, , South Korea
Pusan, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Chernivtsy, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
527.51
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.