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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07533786

Enrollment

200

Registered

2026-04-16

Start date

2026-05-22

Completion date

2026-11-22

Last updated

2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain After Surgery

Brief summary

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.

Interventions

DRUGHSK55718 dose level1

Patients administrated with HSK55718 at dose level 1

DRUGHSK55718 dose level2

Patients administrated with HSK55718 at dose level 2

DRUGHSK55718 dose level 3

Patients administrated with HSK55718 at dose level 3

DRUGPlacebo control

Patients administrated with placebo

DRUGmorphine

Patients administrated with morphine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Sum of Pain Intensity Differences (SPID)	24 hours

Secondary

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

Countries

China

Contacts

CONTACTYongrui Wang

wangyr@haisco.com028-67258779

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026