A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain

Официальное название

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Pregabalin Capsule Controlled, Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

Обзор

This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo.

Вмешательства

• Препарат HRS-2129 Tablets
  HRS-2129 tablets.
• Препарат HRS-2129 Placebo
  HRS-2129 placebo.
• Препарат Pregabalin Capsules
  Pregabalin capsules.
• Препарат Pregabalin Capsules Placebo
  Pregabalin capsules placebo.

Первичные конечные точки

• Compare the change from baseline in Average Daily Pain Score (ADPS) between HRS-2129 and placebo at Week 4. [Срок оценки: Baseline and Week 4.]

Вторичные конечные точки (9)

• Compare the response rate between HRS-2129 and placebo at Week 4 (Proportion of subjects whose ADPS decreased by ≥ 30% and ≥ 50% from baseline). [Срок оценки: Baseline and Week 4.]
• Compare the change from baseline in ADPS between HRS-2129 and placebo at Week 1 to 4. [Срок оценки: From Week 1 to Week 4.]
• Compare the change from baseline in Visual Analog Scale (VAS) between HRS-2129 and placebo at Week 4. [Срок оценки: Baseline and Week 4.]
• Compare the change from baseline in Short-Form McGill Pain Questionnaire (SF-MPQ) between HRS-2129 and placebo at Week 4. [Срок оценки: Baseline and Week 4.]
• Compare the Patient Global Impression of Change (PGIC) between HRS-2129 and placebo at Week 4. [Срок оценки: At Week 4.]
• Compare the change from baseline in Average Daily Sleep Interference score (ADSIS) between HRS-2129 and placebo at Week 4. [Срок оценки: Baseline and Week 4.]
• Number and severity of serious adverse events (SAEs). [Срок оценки: From Week 1 to Week 6.]
• Number and severity of adverse events (AEs). [Срок оценки: From Week 1 to Week 6.]
• Population Pharmacokinetics (PopPK) characteristics of HRS-2129 in Chinese patients with diabetic peripheral neuropathic pain - Serum concentration of HRS-2129. [Срок оценки: From Day 0 to Day 30.]

Критерии участия

Критерии включения

• Able and willing to provide a written informed consent.
• Males or females aged ≥18years of age inclusive.
• Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 3 months.
• HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening as far as possible.
• At Screening, pain scale (Visual Analog Scale, VAS) of ≥ 40 mm and < 90 mm.

Критерии исключения

• Subjects with a history of severe allergies.
• Peripheral neuropathy or pain unrelated to diabetic peripheral neuropathy (DPN) that may confuse the assessment of diabetic peripheral neuropathic pain (DPNP).
• Subjects with abnormal liver and renal function.
• Corrected QT Interval (QTc): > 450 ms (male), > 470 ms (female).
• Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of diabetic peripheral neuropathic pain (DPNP).
• History of suicidal behavior or attempted suicide.
• Participated in another clinical study within 3 months 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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• China-Japan Friendship Hospital — Пекин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин

Идентификаторы

NCT: NCT07377721 · HRS-2129-105

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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