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

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

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
United States, California
Los Angeles, California, United States, 90027
United States, Florida
Jacksonville, Florida, United States, 32207
Tampa, Florida, United States, 33614
United States, Illinois
Springfield, Illinois, United States, 62702
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Shreveport, Louisiana, United States, 71106
United States, Missouri
St Louis, Missouri, United States, 63110
United States, New York
Buffalo, New York, United States, 14222
Lake Success, New York, United States, 11042
Tarrytown, New York, United States, 10591
United States, North Carolina
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Akron, Ohio, United States, 44308
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Dallas, Texas, United States, 75235
Houston, Texas, United States, 77030
United States, Utah
Salt Lake City, Utah, United States, 84132
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Belgium
Gent, Belgium, 9000
Brazil
Santo Andre, Brazil, 09060-650
Sao Paulo, Brazil, 05403-000
Canada
Halifax, Canada, B3K 6R8
Montreal, Canada, H3T 1J5
Montreal, Canada, H3H 1P3
Toronto, Canada, M5G 1X8
Germany
Berlin, Germany, 10115
Deggendorf, Germany, 94469
Essen, Germany, 45122
Hamburg, Germany, 22763
Mainz, Germany, 55101
India
Ahmedabad, India, 380-006
Belgaum, India, 590-010
Bengaluru, India, 560-010
Hyderabaad, India, 500-029
Kochin, India, 682-026
Lucknow, India, 226-014
Lucknow, India, 226-003
Ludhiana, India, 141-008
Ludhiana, India, 141-001
Manipal, India, 576-104
Mumbai, India, 400-008
Nadiad, India, 387-001
Nagpur, India
New Delhi, India, 110-029
Pune, India, 411-053
Pune, India, 411-001
Italy
Cagliari, Italy, 09134
Firenze, Italy, 50139
Roma, Italy, 00165
Korea, Republic of
Gwangju, Korea, Republic of, 501-757
In Cheon, Korea, Republic of, 400-711
Pusan, Korea, Republic of, 602-739
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 120-752
Seoul, Korea, Republic of, 138-736
Mexico
Leon, Mexico, 37660
Puebla, Mexico, CP 72190
Philippines
Manila, Philippines, 1000
Pasig City, Philippines, 1604
Quezon City, Philippines, 1104
Russian Federation
Moscow, Russian Federation, 119991
St. Petersburg, Russian Federation, 194100
South Africa
Bloemfontein, South Africa, 9300
Cape Town, South Africa, 7700
Johannesburg, South Africa
Pretoria, South Africa, 0028
Roodepoort, South Africa
Spain
Barcelona, Spain, 08025
Madrid, Spain, 28046
Malaga, Spain, 29011
Ukraine
Chernivtsy, Ukraine, 58002
Sponsors and Collaborators
Astellas Pharma Inc
Boehringer Ingelheim
Investigators
Study Director: Use Central Contact Boehringer Ingelheim
  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
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014