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

This study has been completed.

First Received: June 19, 2006 Last Updated: July 22, 2009 History of Changes

Sponsor:	Astellas Pharma Inc
Collaborator:	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.

Condition	Intervention	Phase
Bladder, Neurogenic	Drug: tamsulosin hydrochloride	Phase II

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

Resource links provided by NLM:

Drug Information available for: Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

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 ]

Enrollment:	143
Study Start Date:	April 2006
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Show 72 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Director:

Use Central Contact

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc. ( Director )
Study ID Numbers:	527.66
Study First Received:	June 19, 2006
Last Updated:	July 22, 2009
ClinicalTrials.gov Identifier:	NCT00340704 History of Changes
Health Authority:	United States: Food and Drug Administration; 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

Keywords provided by Astellas Pharma Inc:

tamsulosin
pediatric
neurogenic bladder

Additional relevant MeSH terms:

Urinary Bladder, Neurogenic
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Antineoplastic Agents
Physiological Effects of Drugs
Nervous System Diseases
Urinary Bladder Diseases

Adrenergic alpha-Antagonists
Pharmacologic Actions
Signs and Symptoms
Urologic Diseases
Therapeutic Uses
Tamsulosin
Neurologic Manifestations
Adrenergic Antagonists

ClinicalTrials.gov processed this record on February 08, 2010