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Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal Gastrectomy

NCT07330063 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-01-09

No results posted yet for this study

Summary

Anruikefen is a peripherally highly selective kappa receptor agonist that does not easily cross the blood-brain barrier, resulting in a low incidence of central adverse reactions such as respiratory depression, sedation, and addiction. As a Class 1 new drug, it was approved for marketing in China on May 13, 2025, and is indicated for the treatment of postoperative pain following abdominal surgery. Results from two Phase Ⅲ randomized controlled trials (RCTs) of Anruikefen have demonstrated its significant analgesic efficacy, with the incidence of postoperative nausea and vomiting (PONV) being 50% significantly lower than that in the placebo group, which confirms the favorable safety profile of Anruikefen Injection.

Therefore, this investigator-initiated trial (IIT) is designed to further verify the efficacy and safety of Anruikefen in patients undergoing total laparoscopic distal gastrectomy for gastric cancer.

Conditions

  • Gastrectomy

Interventions

DRUG

Anruikefen (Intravenous Bolus)

Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

DRUG

Anruikefen (Intravenous Infusion)

Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.

DRUG

Placebo Group

Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07330063 on ClinicalTrials.gov