PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder
This study has been completed.
Sponsor:
Astellas Pharma Inc
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00340704
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Hide Study LocationsLocations
| 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 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 21, 2013