HR021618 in Moderate to Severe Pain After Abdominal Surgery

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

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

Study Overview

• Status: Unknown
• Conditions: Pain After Abdominal Surgery
• Intervention / Treatment: Drug: HR021618; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects with a history of abdominal surgery
2. Subjects had hemorrhagic disorders
3. Subjects had cardiac, serious hepatic or renal, cardiovascular or cerebrovascular, metabolic, psychiatric disorders, chronic pain, or malignant tumors
4. Subjects with poor blood pressure control after medication
5. Abnormal QTc
6. Abnormal random blood glucose
7. Abnormal values in the laboratory
8. 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
9. 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
10. Pregnant or nursing women
11. No birth control during the specified period of time
12. Participated in clinical trials of other drugs (received experimental drugs)
13. The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A	Drug: HR021618; Treatment group A: HR021618 injection
Placebo Comparator: Treatment group B	Drug: Placebo; Treatment group B: Saline injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC48	Area under the pain intensity-time curve.	48 hours after recovery from anesthesia] Area under the pain intensity-time curve.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total consumption of morphine over 0-48, 0-24, 24-48 hours	Total consumption of morphine after recovery from anesthesia.	48 hours after recovery from anesthesia
AUC3, AUC24, AUC15-21, AUC18-24, AUC24-28, AUC39-45, AUC42-48	Area under the pain intensity-time curve.	48 hours after recovery from anesthesia
Time of the first dose of rescue analgesia	Time of the first dose of rescue analgesia after recovery from anesthesia.	48 hours after recovery from anesthesia
Proportion of subjects receiving rescue analgesia	Proportion of subjects receiving rescue analgesia after recovery from anesthesia.	48 hours after recovery from anesthesia
Frequency of doses of rescue analgesia	Frequency of doses of rescue analgesia after recovery from anesthesia.	48 hours after recovery from anesthesia
Subjects' satisfaction rating	Subjects' satisfaction rating.	48 hours after recovery from anesthesia
Anesthesiologist satisfaction rating	Anesthesiologist satisfaction rating.	48 hours after recovery from anesthesia

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Anticipated): June 25, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HR021618-203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No