A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Abdominal Surgery

Официальное название

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK55718 Injection for Postoperative Pain Treatment in Abdominal Surgery

Обзор

This is a multi-center, randomized, double-blind, double-dummy, placebo/active-controlled study. 200 subjects undergoing abdominal surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 group, morphine group, and placebo group.

Вмешательства

• Препарат HSK55718 dose level1
  Patients administrated with HSK55718 at dose level 1
• Препарат HSK55718 dose level2
  Patients administrated with HSK55718 at dose level 2
• Препарат HSK55718 dose level 3
  Patients administrated with HSK55718 at dose level 3
• Препарат Placebo control
  Patients administrated with placebo
• Препарат morphine
  Patients administrated with morphine

Первичные конечные точки

• Sum of Pain Intensity Differences (SPID) [Срок оценки: 24 hours]

Вторичные конечные точки (4)

• Sum of Pain Intensity Differences (SPID) in other time frame [Срок оценки: 0-12 hours, 12-24 hours, 24-48 hours, 48 hours]
• Number of times rescue analgesic medications were administered. [Срок оценки: 48 hours]
• Time to Pain Relief [Срок оценки: 0-48 hours]
• Postoperative Analgesia Satisfaction Score [Срок оценки: 48 hours]

Критерии участия

Критерии включения

• Age ≥18 years old, regardless of gender;
• 18 kg/m2≤BMI≤30 kg/m2;
• American Society of Anesthesiologists (ASA) gradeⅰ-ⅲ;
• Accept abdominal surgery under general anesthesia;
• Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;
• Fully understand and voluntarily participate this trial, and sign the informed consent form;

Критерии исключения

• A history of cardiovascular, respiratory, neurological, or psychiatric diseases that meet the protocol-defined exclusion criteria.
• Clinically significant abnormalities in laboratory tests during the screening period.
• A history of severe drug allergy or known allergy to the investigational drug.
• Continuous use of opioid analgesics for more than 10 days for any reason within 3 months prior to randomization.
• Use of any medication that may affect analgesia, where the last dose was administered less than 5 half-lives of that drug before randomization.
• A history of drug abuse, substance abuse, and/or alcohol abuse within the past year.
• Pregnant or lactating women.
• Participation in another drug clinical trial within 3 months prior to the screening period.
• Presence of any sensory dysfunction.
• Presence of any painful physical condition.
• Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.

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

• The Third Xiangya Hospital of Central South University — Чанша
• Sichuan Provincial People's Hospital — Чэнду

Идентификаторы

NCT: NCT07533786 · HSK55718-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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