A Trial of HR021618 in Postsurgical Pain Management

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

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.

Study Overview

• Status: Unknown
• Conditions: Postsurgical Pain Management
• Intervention / Treatment: Drug: HR021618; Drug: HR021618; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Shanghai Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment group A	Drug: HR021618; Treatment group A:HR021618; high dose; Drug: HR021618; Treatment group B:HR021618; low dose
EXPERIMENTAL: Treatment group B	Drug: HR021618; Treatment group A:HR021618; high dose; Drug: HR021618; Treatment group B:HR021618; low dose
PLACEBO_COMPARATOR: Treatment group C	Drug: Placebo; Treatment group C: HR021618 blank preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 17, 2020
• Primary Completion (ACTUAL): August 3, 2021
• Study Completion (ANTICIPATED): August 8, 2021

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (ACTUAL): January 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: HR021618-202

Drug and device information, study documents

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