Набор скоро начнётся NCT07641517

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain

Фаза II С лечением Osteoarthritis, Knee Chronic Pain

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: LY4065967, Placebo.
Кому может быть актуально: Состояния в реестре: Osteoarthritis, Knee, Chronic Pain. Базовые параметры: от 40 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, Пуэрто-Рико
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

Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Osteoarthritis

Обзор

The main purpose of this study is to test the safety and efficacy of study drug for the treatment of knee pain due to osteoarthritis (OA). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.

Вмешательства

Препарат LY4065967
Administered orally
Препарат Placebo
Administered orally

Первичные конечные точки

Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS) [Срок оценки: Baseline, Week 8]

Вторичные конечные точки (6)

Change From Baseline in the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale [Срок оценки: Baseline, week 8]
Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change [Срок оценки: Baseline, Week 8]
Change From Baseline for Worst Pain Intensity as Measured by NRS [Срок оценки: Baseline, Week 8]
Change From Baseline in the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale) [Срок оценки: Baseline, Week 8]
Change from Baseline in Emotional Functioning as Measured by the EuroQol-5D 5 Level Questionnaire (EQ 5D 5L) [Срок оценки: Baseline, Week 8]
Total Amount of Rescue Medication Used Daily During the Treatment Phase [Срок оценки: Baseline, Week 8]

Критерии участия

Критерии включения

Have presence of index knee pain for more than 12 weeks at screening
Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee
Have a body mass index ≤40 kilograms per meter squared (kg/m²) (inclusive)
Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening

Критерии исключения

Are pregnant or breastfeeding
Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to screening
Have presence of surgical hardware or other foreign body in the index knee
Have ongoing complex regional pain syndrome or other concurrent medical condition that could interfere with the evaluation of pain in the index knee.
Have had any joint replacement of the lower extremity, such as hip, knee or ankle, in the 6 months prior to screening
Have an abnormal blood pressure (BP) (systolic BP greater than 140 millimeters mercury (>140 mm Hg) and diastolic BP>90 mm Hg) at screening
Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет