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NCT Number: NCT07533786

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Third Xiangya Hospital of Central South University, Changsha, Hunan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

HSK55718 dose level1

Drug

Patients administrated with HSK55718 at dose level 1

HSK55718 dose level2

Drug

Patients administrated with HSK55718 at dose level 2

HSK55718 dose level 3

Drug

Patients administrated with HSK55718 at dose level 3

Placebo Control

Drug

Patients administrated with placebo

Morphine

Drug

Patients administrated with morphine

Primary outcomes

  1. Sum of Pain Intensity Differences (SPID)

    Time frame: 24 hours

Secondary outcomes

  1. Sum of Pain Intensity Differences (SPID) in other time frame

    Time frame: 0-12 hours, 12-24 hours, 24-48 hours, 48 hours

  2. Number of times rescue analgesic medications were administered.

    Time frame: 48 hours

  3. Time to Pain Relief

    Time frame: 0-48 hours

  4. Postoperative Analgesia Satisfaction Score

    Time frame: 48 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Yongrui Wang

CONTACT

[email protected]

028-67258779

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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