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

NCT07533786 | Not Yet Recruiting Phase 2

• 1 other identifier: HSK55718-201
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain After Surgery

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Differences (SPID)

  24 hours

Secondary Outcomes (4)

• 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

Study Arms (5)

HSK55718 dose level1

EXPERIMENTAL

Drug: HSK55718 dose level 1

HSK55718 dose level 2

EXPERIMENTAL

Drug: HSK55718 dose level 2

HSK55718 dose level 3

EXPERIMENTAL

Drug: HSK55718 dose level 3

Placebo control

PLACEBO COMPARATOR

Drug: placebo

Actice control

ACTIVE COMPARATOR

Drug: morphine

Interventions

HSK55718 dose level 1 DRUG

Patients administrated with HSK55718 at dose level 1

HSK55718 dose level1

HSK55718 dose level 2 DRUG

Patients administrated with HSK55718 at dose level 2

HSK55718 dose level 2

HSK55718 dose level 3 DRUG

Patients administrated with HSK55718 at dose level 3

HSK55718 dose level 3

placebo DRUG

Patients administrated with placebo

Placebo control

morphine DRUG

Patients administrated with morphine

Actice control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old, regardless of gender;
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Yongrui Wang

CONTACT

028-67258779; wangyr@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)