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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • HSK55718 dose level1
  • HSK55718 dose level2
  • HSK55718 dose level 3
  • Placebo control
  • morphine

Treatment groups

200 Participants
are divided into 5 treatment groups