УКР  |  ENG

Клинические исследования в Украине

Форум Пациентам

Исследования / № 00350415

Описание
Краткое названиеA Double Blind Study for the Treatment of Acute Ulcerative Colitis
Полное названиеA Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis.
СпонсорWarner Chilcott
Industry
ИсточникWarner Chilcott
Под контролемUnited States: Food and Drug Administration
No
Краткое описаниеA Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the
Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day
(400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND
III).
СостояниеЗавершено
Дата началаJune 2006
ФазаPhase 3
Подробное описаниеThis is a double-blind, randomized, multi-center, multi-national, active-control study in
patients who are experiencing a moderately active flare of UC. Patients will be randomly
assigned to receive either Asacol 2.4 g/day (400 mg tablet) or Asacol 4.8 g/day (800 mg
tablet) for 6 weeks. Patients will be randomized to one of the 2 treatment groups in a 1:1
ratio. The objective of the study is to evaluate the safety and efficacy of Asacol 4.8
g/day (800 mg tablet) compared to Asacol 2.4 g/day (400 mg tablet) in this patient
population. Following successful screening, patients will be randomized to one of the two
treatment arms. Patients will be evaluated after 6 weeks of treatment with an interim visit
after 3 weeks.
Вид исследованияAllocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Набор0
КритерииInclusion Criteria:

- Patients 18-75 years with a confirmed diagnosis of moderately active flare of
ulcerative colitis.

- Female patients need to be postmenopausal or using adequate contraception.

Exclusion Criteria:

- Patients with isolated proctitis

- Patients with comorbidities or an investigative or commercialized treatments
confounding interpretation of study results or compromising patients' safety in the
trial.
ПолBoth
Минимальный возраст18 Years
Максимальный возраст75 Years
УсловиеUlcerative Colitis
Применяемое лечение
DrugMesalamine
Контакты и расположение
Zabolotnogo , 65025Research Facility
Kharkiv , 61037Research Facility
Kyiv , 04053Research Facility
Simpheropol , 95000Research Facility
Zaporizhzhya , 69050Research Facility
2011 © Клинические испытания в Украине