HR021618 in Moderate to Severe Pain After Abdominal Surgery

Phase 2

Completed

• Conditions: Pain After Abdominal Surgery
• Interventions: Drug: HR021618; Drug: Placebo

• Registration Number: NCT04811053
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-23
• Study Start: 2021-04-12
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	HR021618	-
Treatment group B	Placebo	-

Primary Outcome Measures

Name	Time	Method
AUC48	48 hours after recovery from anesthesia] Area under the pain intensity-time curve.	Area under the pain intensity-time curve.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China