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Идёт набор NCT05986292

A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

Фаза II С лечением Osteoarthritis, Knee Diabetic Neuropathic Pain Chronic Low-back 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: LY3016859 ISA, LY3556050 ISA, LY3526318 ISA, LY3857210 ISA.
Кому может быть актуально
Состояния в реестре: Osteoarthritis, Knee, Diabetic Neuropathic Pain, Chronic Low-back Pain. Базовые параметры: от 18 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

A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain

Обзор

The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Подробное описание

The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing.

Note: Results for all outcomes are posted in the intervention records. No need for duplication.

Вмешательства

  • Препарат LY3016859 ISA
    Administered intravenously (IV)
  • Препарат LY3556050 ISA
    Administered orally
  • Препарат LY3526318 ISA
    Administered orally
  • Препарат LY3857210 ISA
    Administered orally
  • Препарат Placebo Oral
    Placebo administered orally
  • Препарат Placebo
    Placebo administered IV

Первичные конечные точки

  • Number of Participants Who Were Allocated to Each ISA [Срок оценки: Baseline, Up to Week 8]

Критерии участия

Критерии включения

  • have a visual analog scale (VAS) pain value >40 and <95 at screening and prerandomization screening.
  • have a history of daily pain for at least 12 weeks based on participant report or medical history
  • have a value of ≤30 on the pain catastrophizing scale
  • have a body mass index <40 kilogram/square meter (kg/m²) (inclusive)
  • are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.
  • are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study

Критерии исключения

  • have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia
  • have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques)
  • have surgery planned during the study for any reason, related or not to the disease state under evaluation.
  • have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.
  • have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.
  • have fibromyalgia
  • have substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)
  • have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.
  • have a positive human immunodeficiency virus (HIV) test result at screening
  • have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to 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
Скрининг

Центры проведения

США · 62 центра
  • Central Research Associates — Birmingham
  • Simon Williamson Clinic — Birmingham
  • Synexus Clinical Research - Glendale — Glendale
  • Synexus Clinical Research US, Inc. — Phoenix
  • Arizona Research Center — Phoenix
  • Alliance for Multispecialty Research, LLC — Tempe
  • Irvine Clinical Research — Irvine
  • Desert Oasis Healthcare Medical Group — Palm Springs
  • … и ещё 54 центра
Пуэрто-Рико · 2 центра
  • Ponce Medical School Foundation Inc. — Ponce
  • Latin Clinical Trial Center — San Juan

Публикации

  • Knopp KL, Downing AM, Anthony L, Chaterjee S, Price K, Sparks J. An innovative phase 2 chronic pain master protocol design to assess novel mechanisms in multiple pain types. Pain Rep. 2024 Oct 16;9(6):e1203. doi: 10.1097/PR9.0000000000001203. eCollection 2024 Dec. PMID 39430683

Идентификаторы

NCT: NCT05986292 · 17511 · H0P-MC-CPMP

Первоисточники (государственные реестры)

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