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Идёт набор NCT07186751

The Efficacy and Safety of Pregabalin Combined With Venlafaxine in Patients With Fibromyalgia

Без фазы С лечением Fibromyalgia Pregabalin Venlafaxine 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: Pregabalin, Pregabalin with venlafaxine.
Кому может быть актуально
Состояния в реестре: Fibromyalgia, Pregabalin, Venlafaxine, 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
Китай
Следующий шаг
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Официальное название

Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Other Neuromodulatory Drugs (Venlafaxine) in the Treatment of Fibromyalgia: A Multicenter Clinical Study

Обзор

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Selective serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine, has demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Several studies have highlighted benefits of venlafaxine in FM. We hypothesize that the combination of pregabalin with venlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.

Вмешательства

  • Препарат Pregabalin
    In general, for the pregabalin monotherapy group (Pregabalin Capsules, Pfizer, New York, USA), treatment will be initiated at 150 mg/day, administered in two divided doses. After 7 days, the dose will be increased to 300 mg/day. Thereafter, based on individual response and tolerability, the dose may be further increased to a maximum of 450 mg/day.
  • Препарат Pregabalin with venlafaxine
    For the combination therapy group, participants will receive both pregabalin and venlafaxine (Venlafaxine Hydrochloride Sustained-Release Capsules, Pfizer, Co Kildare, Ireland). The dose titration for pregabalin will be identical to that of the monotherapy group. Concurrently, venlafaxine will be initiated at 75 mg/day. If well-tolerated, the dose may be increased in 75 mg/day increments at weekly intervals, guided by clinical response and side effects profile, to a maximum dose of 225 mg/day.

Первичные конечные точки

  • The average pain intensity [Срок оценки: At the 4-weeks]
Вторичные конечные точки (9)
  • The worst pain intensity [Срок оценки: At the weeks 1, 2, 4, 8, and 12]
  • The proportion of patients achieving pain reduction [Срок оценки: At the weeks 1, 2, 4, 8, and 12]
  • Dose of pregabalin and/or venlafaxine [Срок оценки: At the weeks 1, 2, 4, 8, and 12]
  • The Revised FM Impact Questionnaire [Срок оценки: At the weeks 1, 2, 4, 8, and 12]
  • The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales [Срок оценки: At the weeks 1, 2, 4, 8, and 12]
  • The short-form 36 Health Survey (SF-36) [Срок оценки: At the weeks 1, 2, 4, 8, and 12]
  • The Medical Outcomes Study Sleep Scale (MOS) [Срок оценки: At the weeks 1, 2, 4, 8, and 12]
  • The Beck Depression Inventory-Ⅱ (BD-Ⅱ) [Срок оценки: At the weeks 1, 2, 4, 8, and 12]
  • Adverse Events [Срок оценки: Through study completion, an average of 12 weeks]

Критерии участия

Критерии включения

  • Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
  • Aged more than 18 years;
  • Suffering from moderate to severe FM with 11-point numeric rating scale (NRS) score more than 4 at baseline that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
  • Agreed to sign the informed consent form.

Критерии исключения

  • A history of psychiatric disease;
  • Hypersensitivity or have contraindications to pregabalin, venlafaxine;
  • Pregnancy or breastfeeding;
  • Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, significant cardiac dysfunction, or chronic hepatic or renal dysfunction;
  • With acute or chronic pain conditions other than FM.

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
Открытое
Основная цель
Лечение

Центры проведения

Китай · 2 центра
  • Beijing Tiantan Hospital, Beijing, Beijing 100070 — Beijin
  • Beijing Tiantan Hospital, Beijing, Beijing 100070 — Пекин

Идентификаторы

NCT: NCT07186751 · KY2025-217-03-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗