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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00340704
First received: June 19, 2006
Last updated: June 1, 2015
Last verified: May 2015
  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:


Further study details as provided by Boehringer Ingelheim:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 72 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00340704     History of Changes
Other Study ID Numbers: 527.66
Study First Received: June 19, 2006
Last Updated: June 1, 2015
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 Boehringer Ingelheim:
tamsulosin
pediatric
neurogenic bladder

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Tamsulosin
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on July 01, 2015