Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00340704
First received: June 19, 2006
Last updated: July 22, 2009
Last verified: July 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: 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.

Resource links provided by NLM:

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
Experimental: 1. Low dose group Drug: tamsulosin hydrochloride
oral
Experimental: 2. Medium dose group Drug: tamsulosin hydrochloride
oral
Experimental: 3. High dose group 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: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00340704     History of Changes
Other Study ID Numbers: 527.66
Study First Received: June 19, 2006
Last Updated: July 22, 2009
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 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
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Tamsulosin
Adrenergic alpha-1 Receptor Antagonists
 Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013