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

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

This study is currently recruiting participants.
Verified by Astellas Pharma Inc, November 2008

Sponsors and Collaborators: Astellas Pharma Inc
Boehringer Ingelheim Pharmaceuticals
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00340704

Purpose

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.

Study Type: Interventional
Study Design: Open Label, Parallel Assignment, Randomized, Safety/Efficacy Study, Treatment, Uncontrolled
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.

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

* Responder rate who achieves a decrease in their detrusor leak point pressure to less than 40cm H2O [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

* Improvement or stabilization of hydronephrosis and/or hydroureter base [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
* Assessment of pharmacokinetics parameters [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 143
Study Start Date: April 2006
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

1. Low dose group: Experimental
Drug: tamsulosin hydrochloride oral
2. Medium dose group: Experimental
Drug: tamsulosin hydrochloride oral
3. High dose group: Experimental
Drug: tamsulosin hydrochloride oral

Eligibility

Ages Eligible for Study: 2 Years to 16 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
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

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00340704

Contacts
Contact: Boehringer Ingelheim Pharmaceuticals, Inc. (203) 798-4314

Sponsors and Collaborators
Astellas Pharma Inc
Boehringer Ingelheim Pharmaceuticals

Responsible Party: Astellas Pharma Inc. ( Director )
Study ID Numbers: 527.66
Study First Received: June 19, 2006
Last Updated: November 12, 2008
ClinicalTrials.gov Identifier: NCT00340704
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products; Brazil: Ministry of Health; Canada: Canadian Institutes of Health Research; Germany: Federal Institute for Drugs and Medical Devices; India: Ministry of Health; Italy: Ministry of Health; Korea: Food and Drug Administration; Mexico: Ministry of Health; Philippines: Department of Health; Russia: Ministry of Health and Social Development of the Russian Federation; South Africa: Department of Health; Spain: Ministry of Health; Ukraine: Ministry of Health; United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 09, 2009