Идёт набор NCT07089888
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
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: Allopurinol, Dotinurad.
- Кому может быть актуально
- Состояния в реестре: Tophaceous Gout. Базовые параметры: 18 лет — 75 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 →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Tophaceous Gout
Обзор
The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with tophaceous gout.
Вмешательства
- Препарат Allopurinol
Over-encapsulated tablets containing active drug substance administered orally (PO). - Препарат Dotinurad
Over-encapsulated tablets containing active drug substance administered PO.
Первичные конечные точки
- Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24 [Срок оценки: Week 24]
Вторичные конечные точки (12)
- Percentage of Participants who Experience Complete Response (CR) or Partial Response (PR) of ≥1 Target Tophus at Week 76 [Срок оценки: Week 76]
- Percentage of Participants who Experience CR of ≥1 Target Tophus at Week 76 [Срок оценки: Week 76]
- Percentage of Participants with an sUA Level <4.0 mg/dL at Week 24 [Срок оценки: Week 24]
- Mean Rate of Gout Flares Requiring Treatment from Week 36 Through Week 76 [Срок оценки: Week 36 through Week 76]
- Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24 and No Gout Flares Requiring Treatment from Week 36 Through Week 76 [Срок оценки: Week 24 and Week 36 through Week 76]
- Mean Change from Baseline in sUA at Week 24 [Срок оценки: Baseline and Week 24]
- Mean Percent Change from Baseline in the Sum of the Areas for all Target Tophi at Each Visit [Срок оценки: Baseline to Week 80]
- Percentage of Participants who Do Not have a Gout Flare Requiring Treatment from Week 36 through Week 76 [Срок оценки: Week 36 through Week 76]
- Percentage of Participants with an sUA Level <5.0 mg/dL at Each Visit [Срок оценки: Up to Week 80]
- Percentage of Participants with an sUA Level <4.0 mg/dL at Each Visit [Срок оценки: Up to Week 80]
- Percentage of Participants with an sUA Level <3.0 mg/dL at Each Visit [Срок оценки: Up to Week 80]
- Absolute Change from Baseline in sUA Levels at Each Visit [Срок оценки: Baseline to Week 80]
Критерии участия
Критерии включения
- Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
- Diagnosis of gout based on 2015 American College of Rheumatology-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year.
- Has ≥1 measurable tophus on the hands/wrists and/or feet/ankles between Screening and Day 1. A measurable tophus is defined as ≥5 mm and ≤30 mm in the longest diameter.
- sUA level ≥5.0 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
- Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding.
- Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of study drug.
Критерии исключения
- History of or presence of kidney stones within 1 year prior to Screening.
- History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
- Hypersensitivity or intolerance to dotinurad or to colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs).
- Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
- Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 89 центров
- The Kirklin Clinic of University of Alabama Birmingham Hospital — Birmingham
- Alabama Clinical Therapeutics — Birmingham
- G & L Research — Foley
- Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert — Gilbert
- Arizona Arthritis & Rheumatology Associates (AARA) - Glendale — Glendale
- Arizona Arthritis & Rheumatology Associates (AARA) - Mesa — Mesa
- Del Sol Research Management - Tucson East — Tucson
- Medvin Clinical Research - Covina — Covina
- … и ещё 81 центр
Идентификаторы
NCT: NCT07089888 · FYU-981-CRYS-302 · 2024-520207-84-00