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Completed

NCT Number: NCT04811053

HR021618 in Moderate to Severe Pain After Abdominal Surgery

The study is being conducted to evaluate the efficacy and safety of HR021618 in the treatment of moderate to severe pain after abdominal surgery.

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Key information

Conditions

Pain After Abdominal Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able and willing to provide a written informed consent
  • Subjects requiring elective general anesthesia abdominal surgery
  • Male or female
  • Meet BMI standard
  • Conform to the ASA Physical Status Classification

Exclusion criteria

  • Subjects with a history of abdominal surgery
  • Subjects had hemorrhagic disorders
  • Subjects had cardiac, serious hepatic or renal, cardiovascular or cerebrovascular, metabolic, psychiatric disorders, chronic pain, or malignant tumors
  • Subjects with poor blood pressure control after medication
  • Abnormal QTc
  • Abnormal random blood glucose
  • Abnormal values in the laboratory
  • Allergic to meloxicam or any excipient of HR021618, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study
  • Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives
  • Pregnant or nursing women
  • No birth control during the specified period of time
  • Participated in clinical trials of other drugs (received experimental drugs)
  • The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Treatment and study plan

HR021618

Drug

Treatment group A: HR021618 injection

Placebo

Drug

Treatment group B: Saline injection

Primary outcomes

  1. AUC48

    Time frame: 48 hours after recovery from anesthesia] Area under the pain intensity-time curve.

    Area under the pain intensity-time curve.

Secondary outcomes

  1. Total consumption of morphine over 0-48, 0-24, 24-48 hours

    Time frame: 48 hours after recovery from anesthesia

    Total consumption of morphine after recovery from anesthesia.

  2. AUC3, AUC24, AUC15-21, AUC18-24, AUC24-28, AUC39-45, AUC42-48

    Time frame: 48 hours after recovery from anesthesia

    Area under the pain intensity-time curve.

  3. Time of the first dose of rescue analgesia

    Time frame: 48 hours after recovery from anesthesia

    Time of the first dose of rescue analgesia after recovery from anesthesia.

  4. Proportion of subjects receiving rescue analgesia

    Time frame: 48 hours after recovery from anesthesia

    Proportion of subjects receiving rescue analgesia after recovery from anesthesia.

  5. Frequency of doses of rescue analgesia

    Time frame: 48 hours after recovery from anesthesia

    Frequency of doses of rescue analgesia after recovery from anesthesia.

  6. Subjects' satisfaction rating

    Time frame: 48 hours after recovery from anesthesia

    Subjects' satisfaction rating.

  7. Anesthesiologist satisfaction rating

    Time frame: 48 hours after recovery from anesthesia

    Anesthesiologist satisfaction rating.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of HR021618 in the Treatment of Moderate to Severe Pain After Abdominal Surgery

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2021
Registry last updated
May 15, 2025

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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