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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:


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