УКР  |  ENG

Клинические исследования в Украине

Форум Пациентам

Исследования / № 00585312

Описание
Краткое названиеTrial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)
Полное названиеA Phase III Placebo-Controlled Trial Of Celecoxib In Genotype Positive Subjects With Familial Adenomatous Polyposis
СпонсорPfizer
Industry
ИсточникPfizer
Под контролемUnited States: Food and Drug Administration
Yes
Краткое описаниеTo test whether celecoxib can be used to prevent colon polyp formation in children with
familial adenomatous polyposis (FAP).
СостояниеИдет набор
Дата началаSeptember 2006
ФазаPhase 3
Вид исследованияAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Набор0
КритерииInclusion Criteria:

- Age 10-17 years

- Confirmed non-attenuated FAP genotype based on central genetic testing

- Less than 20 polyps, which need to be removed to render the colon polyp-free before
study drug can be given

Exclusion Criteria:

- Diagnosis of attenuated FAP based on central genetic testing

- Sensitivity to COX-2 inhibitors
ПолBoth
Минимальный возраст10 Years
Максимальный возраст17 Years
УсловиеAdenomatous Polyposis Coli
Применяемое лечение
DrugCelecoxib
DrugPlacebo
Контакты и расположение
Donetsk , 83052Pfizer Investigational Site
Kyiv , 04212Pfizer Investigational Site
2011 © Клинические испытания в Украине