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Completed

NCT Number: NCT04852003

A Trial of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal

The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after endoscopic surgery of the lower abdominal.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

West China Hospital of 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 endoscopic surgery of the lower abdominal
  • Male or female
  • Meet the body mass index standard
  • Conform to the ASA Physical Status Classification

Exclusion criteria

  • Subjects with a history of difficult airway
  • Subjects with a history of mental illness
  • Subjects with a history of cognitive impairment epilepsy
  • Subjects with a history of myocardial infarction or unstable angina pectoris
  • Subjects with atrioventricular block or cardiac insufficiency
  • Subjects with a history of ischemic stroke or transient ischemic attack
  • Subjects with poor blood pressure control after medication
  • Subject with a history of substance abuse and drug abuse
  • Abnormal values in liver function
  • Subjects with an oxygen saturation below 90% on room air
  • Allergic to drugs that may be used during the study
  • Pregnant or nursing women
  • No birth control during the specified period of time
  • Participated in clinical trials of other drugs (received experimental drugs)
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial

Treatment and study plan

SHR0410 Injection

Drug

SHR0410 Injection

Placebo

Drug

Placebo for SHR0410 Injection

Morphine

Drug

Morphine

Primary outcomes

  1. The area under the curve of pain intensity over 24 hours

    Time frame: 24-hours

    Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity, administered over 24 hours.

Secondary outcomes

  1. Total consumption of remedial analgesics from 0h to 24h

    Time frame: 24-hours

    Total consumption of IV morphine

  2. Participant ' satisfaction score for analgesia treatment

    Time frame: 24-hours

    Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 0 to 10, with 0 representing dissatisfied and 10 representing very satisfied.

  3. Investigator satisfaction score for analgesia treatment

    Time frame: 24-hours

    Postoperative analgesia was evaluated by investigators. The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied.

  4. Frequency and severity of adverse events

    Time frame: Day 4（or early termination on Day 3）

    Assessed by monitoring of adverse events. Participants with adverse events found to be related to the study drug will be compared to those receiving placebo or active comparator.

  5. Safety as assessed by vital signs

    Time frame: Day 4（or early termination on Day 3）

    Changes in vital signs such as body temperature, blood pressure, heart rate will be assessed at specified times.

  6. Safety as assessed by laboratory evaluations

    Time frame: Day 4（or early termination on Day 3）

    Assessed by laboratory evaluations at specified times. Participants with clinically significant lab values will be compared to those receiving placebo or active comparator.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase Ⅲ, Randomized, Double-blind, Placebo- and Active-controlled Study of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2021
Registry last updated
Feb 10, 2022

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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