Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00175123 |
Date of registration:
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09/09/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele
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Scientific title:
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Phase 4 Study of the Effect of Botulinum-A Toxin Injected in Neurogenic Overactive Bladders of Children Born With Myelomeningocele |
Date of first enrolment:
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May 2005 |
Target sample size:
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30 |
Recruitment status: |
Active, not recruiting |
URL:
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http://clinicaltrials.gov/show/NCT00175123 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Bettina Jorgensen, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Department of Urology, Aarhus University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Myelomeningocele
- Neurogenic bladder with untreated leak point pressures > 40 mmH2O
- Treated with oxybutynin or other parasympatholytics
Exclusion Criteria:
- Acute urinary tract infection
- Compromised neuromuscular transmission
Age minimum:
2 Years
Age maximum:
16 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myelomeningocele
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Bladder, Neurogenic
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Intervention(s)
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Drug: Botulinum A toxin
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Primary Outcome(s)
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Bladder capacity and pressures: measures from cystometry
[Time Frame: at 4 weeks and 6 months]
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Secondary Outcome(s)
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Urinary continence: score from an incontinence rating scale
[Time Frame: 2 days before and 4 weeks and 6 months after]
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Constipation: score on the Bristol scale
[Time Frame: 4 weeks]
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Secondary ID(s)
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J.nr.20030155
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Botox
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J.nr.2612-2319
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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