A Trial of HR021618 in Postsurgical Pain Management

Postsurgical Pain Management Clinical Trial

Official title:

A Phase Ⅱ, Multicenter, Randomized, Single-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy of HR021618 for Pain Management Following Orthopaedic Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04699175
• Other study ID #: HR021618-202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 17, 2020
• Est. completion date: August 8, 2021

Study information

• Verified date: December 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: August 8, 2021
• Est. primary completion date: August 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postsurgical Pain Management

Intervention

Drug:
• HR021618
Treatment group A:HR021618; high dose
• HR021618
Treatment group B:HR021618; low dose
• Placebo
Treatment group C: HR021618 blank preparation.

Locations

Country	Name	City	State
China	Shanghai Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usage of Morphine, Post Surgery	Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post IP administration.	0 hour to 24 hours after IP administration
Secondary	Usage of Morphine, Post Surgery at other intervals	Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-48 hours after IP administration.	0 hour to 48 hours after IP administration
Secondary	Pain intensity assessed using an 11-point NRS ranging	11-point NPRS ranging from a score of 0 to 10.	Baseline till 48 hours post IP administration
Secondary	Pain relief assessed using an 5-point likert scale	5-point likert scale from a score of 0 to 4.	Baseline till 48 hours post IP administration
Secondary	Time to First Dose of Rescue Analgesia	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.	0 hour to 48 hours after IP administration
Secondary	Frequency of Doses of Rescue Analgesia Utilized Per Subject	Rescue analgesia was available to subjects with inadequately controlled pain upon request.	0 hour to 48 hours after IP administration
Secondary	Proportion of subjects who received Rescue Analgesia	Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.	0 hour to 48 hours after IP administration
Secondary	Patient Global Assessment (PGA) of Pain Control	PGA of pain control was evaluated by subject reported degree of pain control according to a 5 point scale (0-4)	0 hour to 48 hours after IP administration