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

Condition(s) targeted: Bladder, Neurogenic

Intervention: tamsulosin hydrochloride (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Boehringer Ingelheim Pharmaceuticals

Overall contact:
Boehringer Ingelheim Pharmaceuticals, Inc., Phone: (203) 798-4314, Email: jmckay@rdg.boehringer-ingelheim.com

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.

Official title: An Uncontrolled, Open-Label, Titration, Long-Term Safety (up to 12 Months) and Efficacy Study of Tamsulosin Hydrochloride in Children With Neuropathic Bladder, With a Randomized Pharmacokinetic Sub-Study Investigating Low, Medium and High Dose Ranges.

Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Responder rate who achieves a decrease in their detrusor leak point pressure to less than 40cm H2O

Secondary outcome:

Improvement or stabilization of hydronephrosis and/or hydroureter base

Assessment of pharmacokinetics parameters

Minimum age: 2 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

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

Boehringer Ingelheim Pharmaceuticals, Inc., Phone: (203) 798-4314, Email: jmckay@rdg.boehringer-ingelheim.com

Gent 9000, Belgium; Recruiting

Santo Andre 09060-650, Brazil; Recruiting

Sao Paulo 05403-000, Brazil; Recruiting

Montreal H3T 1J5, Canada; Recruiting

Halifax B3K 6R8, Canada; Recruiting

Montreal H3H 1P3, Canada; Recruiting

Toronto M5G 1X8, Canada; Recruiting

Hamburg 22763, Germany; Recruiting

Berlin 10115, Germany; Recruiting

Deggendorf 94469, Germany; Recruiting

Essen 45122, Germany; Recruiting

Mainz 55101, Germany; Recruiting

Kochin 682-026, India; Recruiting

Bengaluru 560-010, India; Recruiting

Mumbai 400-008, India; Recruiting

Nagpur, India; Recruiting

Ludhiana 141-008, India; Recruiting

Ludhiana 141-001, India; Recruiting

Pune 411-001, India; Recruiting

Hyderabaad 500-029, India; Recruiting

Manipal 576-104, India; Recruiting

Ahmedabad 380-006, India; Recruiting

Lucknow 226-003, India; Recruiting

Belgaum 590-010, India; Recruiting

Pune 411-053, India; Recruiting

Nadiad 387-001, India; Recruiting

Lucknow 226-014, India; Recruiting

New Delhi 110-029, India; Recruiting

Cagliari 09134, Italy; Recruiting

Firenze 50139, Italy; Recruiting

Roma 00165, Italy; Recruiting

Seoul 138-736, Korea, Republic of; Recruiting

Gwangju 501-757, Korea, Republic of; Recruiting

In Cheon 400-711, Korea, Republic of; Recruiting

Pusan 602-739, Korea, Republic of; Recruiting

Seoul 110-744, Korea, Republic of; Recruiting

Seoul 120-752, Korea, Republic of; Recruiting

Puebla CP 72190, Mexico; Recruiting

Leon 37660, Mexico; Recruiting

Manila 1000, Philippines; Recruiting

Quezon City 1104, Philippines; Recruiting

Pasig City 1604, Philippines; Recruiting

St. Petersburg 194100, Russian Federation; Recruiting

Moscow 119991, Russian Federation; Recruiting

Johannesburg, South Africa; Recruiting

Roodepoort, South Africa; Recruiting

Pretoria 0028, South Africa; Recruiting

Cape Town 7700, South Africa; Recruiting

Bloemfontein 9300, South Africa; Recruiting

Barcelona 08025, Spain; Recruiting

Madrid 28046, Spain; Recruiting

Malaga 29011, Spain; Recruiting

Chernivtsy 58002, Ukraine; Recruiting

Birmingham, Alabama 35233, United States; Recruiting

Los Angeles, California 90027, United States; Recruiting

Tampa, Florida 33614, United States; Recruiting

Jacksonville, Florida 32207, United States; Recruiting

Springfield, Illinois 62702, United States; Recruiting

Indianapolis, Indiana 46202, United States; Recruiting

Shreveport, Louisiana 71106, United States; Completed

St Louis, Missouri 63110, United States; Recruiting

Lake Success, New York 11042, United States; Withdrawn

Tarrytown, New York 10591, United States; Recruiting

Lake Success, New York 11042, United States; Recruiting

Buffalo, New York 14222, United States; Recruiting

Winston Salem, North Carolina 27157, United States; Recruiting

Akron, Ohio 44308, United States; Recruiting

Oklahoma City, Oklahoma 73104, United States; Recruiting

Nashville, Tennessee 37232, United States; Recruiting

Dallas, Texas 75235, United States; Recruiting

Houston, Texas 77030, United States; Recruiting

Salt Lake City, Utah 84132, United States; Recruiting

Madison, Wisconsin 53792, United States; Recruiting

Starting date: April 2006
Ending date: March 2010
Last updated: November 12, 2008