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Main
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Note: This record shows only the 20 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00551824 |
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Date of registration:
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30/10/2007 |
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Primary sponsor: |
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Public title:
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Evaluation of Topical Mitomycin C as Adjuvant Drug to Esophageal Dilation in Children
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Scientific title:
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Evaluation of Topical Mitomycin C as Adjuvant Drug to Endoscopic Esophageal Dilation in Children |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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10 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00551824 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Marcelo Gancz, M.D. |
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Address:
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Telephone:
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55-11-5576-4093 |
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Email:
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gastroped.endo@gmail.com |
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Affiliation:
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Name:
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Rodrigo S Machado, PhD |
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Address:
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Telephone:
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55-11-5576-4344 |
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Email:
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rodrigo@gastroped.epm.br |
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Affiliation:
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Name:
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Rodrigo S Machado, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Disciplina de Gastroenterologia Pediátrica, UNIFESP/EPM |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- children with esophageal strictures
- and dysphagia
- or stricture preventing endoscope to pass over it.
Exclusion Criteria:
- congenital esophageal stricture
- stricture associated to eosinophilic esophagitis
Age minimum:
6 Months
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Caustic Esophageal Stricture
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Esophageal Stricture
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Peptic Esophageal Stricture
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Post-Surgical Esophageal Stricture
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Intervention(s)
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Drug: Mitomycin C
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Primary Outcome(s)
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Number of days with improved symptom (dysphagia) after dilation session.
[Time Frame: 14 days]
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Secondary Outcome(s)
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Esophageal diameter
[Time Frame: 14 days]
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Secondary ID(s)
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MITOMYCIN
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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