A Trial of HR021618 in Postsurgical Pain Management

Phase 2

• Conditions: Postsurgical Pain Management
• Interventions: Drug: Placebo; Drug: HR021618

• Registration Number: NCT04699175
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

The study is being conducted to evaluate the efficacy, safety of HR021618 and to explore the reasonable dosage of HR021618 for Pain Management after Orthopaedic surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12-17
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-07
• Primary Completion: 2021-08-03
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-06
• Study Completion: 2021-08-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Able and willing to provide a written informed consent
2. Subjects requiring elective Orthopaedic surgery
3. Male or female
4. Meet the weight standard
5. Conform to the ASA Physical Status Classification Postoperative randomization criteria Exclusion Criteria

1、 Sufficient pain to require IVanalgesia assessed by NRS ranging 2、 No evidence of organ insufficiency, or any other abnormality, during or following surgery

Exclusion Criteria

1. History of major surgery
2. History of active or high-risk bleeding disorders
3. History of myocardial infarction or coronary artery bypass
4. History or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study
5. Abnormal values in the laboratory
6. Have a known allergy 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
7. 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
8. Planned/actual admission to the intensive care unit
9. Pregnant or nursing women
10. No birth control during the specified period of time
11. Participated in clinical trials of other drugs (received experimental drugs)
12. 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 C	Placebo	-
Treatment group A	HR021618	-
Treatment group B	HR021618	-

Primary Outcome Measures

Name	Time	Method
Usage of Morphine, Post Surgery	0 hour to 24 hours after IP administration	Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post IP administration.

Secondary Outcome Measures

Name	Time	Method
Patient Global Assessment (PGA) of Pain Control	0 hour to 48 hours after IP administration	PGA of pain control was evaluated by subject reported degree of pain control according to a 5 point scale (0-4)
Proportion of subjects who received Rescue Analgesia	0 hour to 48 hours after IP administration	Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.
Usage of Morphine, Post Surgery at other intervals	0 hour to 48 hours after IP administration	Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-48 hours after IP administration.
Pain relief assessed using an 5-point likert scale	Baseline till 48 hours post IP administration	5-point likert scale from a score of 0 to 4.
Frequency of Doses of Rescue Analgesia Utilized Per Subject	0 hour to 48 hours after IP administration	Rescue analgesia was available to subjects with inadequately controlled pain upon request.
Pain intensity assessed using an 11-point NRS ranging	Baseline till 48 hours post IP administration	11-point NPRS ranging from a score of 0 to 10.
Time to First Dose of Rescue Analgesia	0 hour to 48 hours after IP administration	Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.

Trial Locations

Locations (1)

Shanghai Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China