Идёт набор NCT04314375

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

Фаза IV С лечением Ulcerative Colitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Low Dose Budesonide, High Dose Budesonide, Placebo.
Кому может быть актуально: Состояния в реестре: Ulcerative Colitis. Базовые параметры: 5 лет — 17 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

Обзор

This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products.

Вмешательства

Препарат Low Dose Budesonide
3 milligrams once daily for ages 5 to 11 years 11 months. 6 milligrams once daily for ages 12 to 17 years.
Препарат High Dose Budesonide
6 milligrams once daily for ages 5 to 11 years 11 months. 9 milligrams once daily for ages 12 to 17 years.
Препарат Placebo
Matching placebo once daily.

Первичные конечные точки

The primary efficacy endpoint is the proportion of subjects who achieve clinical remission at Day 56, defined as a total Mayo score of ≤ 1 with subscores of 0 for both rectal bleeding and stool frequency, and a subscore of ≤ 1 for endoscopy. [Срок оценки: 56 days]

Вторичные конечные точки (3)

Proportion of subjects who achieve a Mayo rectal bleeding subscale score of 0 at Day 56. [Срок оценки: 56 days]
Proportion of subjects who achieve a Mayo stool frequency subscale score of 0 at Day 56. [Срок оценки: 56 days]
Proportion of subjects who achieve a Mayo endoscopy subscale score of 0 or 1 at Day 56. [Срок оценки: 56 days]

Критерии участия

Критерии включения

Established diagnosis of UC is based on:

Clinical history
Characteristic endoscopic findings
Histopathology results from biopsies
Age 5 to 17 years, inclusive, at Screening. Subjects should weigh greater than 13.6 kg at Baseline.
Active UC of mild or moderate severity, defined as a total Mayo score between 4 and 10, inclusive, with rectal bleeding subscore of ≥ 1, stool frequency subscore of ≥1 and an endoscopy subscore of ≥ 1.
If on a background oral or rectal 5-ASA, the dose and formulation have remained unchanged for at least 6 weeks prior to Visit 2 (randomization), Baseline and the subject is willing to remain on the same formulation and dose for the duration of the study.

Критерии исключения

Current or prior diagnosis of Crohn's disease or indeterminate colitis.
Limited distal proctitis (disease involving only the first 15 centimeters or less proximal to the anal verge.
Severe UC, defined as total Mayo score >10.
Not currently in an active phase or flare, defined as a total Mayo score <4, or Mayo score between 4 and 10, but Mayo subscore of 0 for rectal bleeding, stool frequency or endoscopy.
Infectious colitis (based on positive microbiologic tests at Screening) or any recent history of infectious colitis (within 30 days prior to Screening).
Prior gastrointestinal surgery, except appendectomy or hernia (e.g., inguinal, umbilical).

NOTE: Prior cholecystectomy is not exclusionary if more than 1 year prior to Screening.