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A Trial of HR021618 in Postsurgical Pain Management

Primary Purpose

Postsurgical Pain Management

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HR021618
HR021618
Placebo
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postsurgical Pain Management

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Changhai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Treatment group A

Treatment group B

Treatment group C

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Pain intensity assessed using an 11-point NRS ranging
11-point NPRS ranging from a score of 0 to 10.
Pain relief assessed using an 5-point likert scale
5-point likert scale from a score of 0 to 4.
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.
Frequency of Doses of Rescue Analgesia Utilized Per Subject
Rescue analgesia was available to subjects with inadequately controlled pain upon request.
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.
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)

Full Information

First Posted
January 6, 2021
Last Updated
August 5, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04699175
Brief Title
A Trial of HR021618 in Postsurgical Pain Management
Official Title
A Phase Ⅱ, Multicenter, Randomized, Single-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy of HR021618 for Pain Management Following Orthopaedic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
August 3, 2021 (Actual)
Study Completion Date
August 8, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postsurgical Pain Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
HR021618 compared with placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group A
Arm Type
Experimental
Arm Title
Treatment group B
Arm Type
Experimental
Arm Title
Treatment group C
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HR021618
Intervention Description
Treatment group A:HR021618; high dose
Intervention Type
Drug
Intervention Name(s)
HR021618
Intervention Description
Treatment group B:HR021618; low dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Treatment group C: HR021618 blank preparation.
Primary Outcome Measure Information:
Title
Usage of Morphine, Post Surgery
Description
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post IP administration.
Time Frame
0 hour to 24 hours after IP administration
Secondary Outcome Measure Information:
Title
Usage of Morphine, Post Surgery at other intervals
Description
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-48 hours after IP administration.
Time Frame
0 hour to 48 hours after IP administration
Title
Pain intensity assessed using an 11-point NRS ranging
Description
11-point NPRS ranging from a score of 0 to 10.
Time Frame
Baseline till 48 hours post IP administration
Title
Pain relief assessed using an 5-point likert scale
Description
5-point likert scale from a score of 0 to 4.
Time Frame
Baseline till 48 hours post IP administration
Title
Time to First Dose of Rescue Analgesia
Description
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.
Time Frame
0 hour to 48 hours after IP administration
Title
Frequency of Doses of Rescue Analgesia Utilized Per Subject
Description
Rescue analgesia was available to subjects with inadequately controlled pain upon request.
Time Frame
0 hour to 48 hours after IP administration
Title
Proportion of subjects who received Rescue Analgesia
Description
Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.
Time Frame
0 hour to 48 hours after IP administration
Title
Patient Global Assessment (PGA) of Pain Control
Description
PGA of pain control was evaluated by subject reported degree of pain control according to a 5 point scale (0-4)
Time Frame
0 hour to 48 hours after IP administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able and willing to provide a written informed consent Subjects requiring elective Orthopaedic surgery Male or female Meet the weight standard 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: History of major surgery History of active or high-risk bleeding disorders History of myocardial infarction or coronary artery bypass History or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study Abnormal values in the laboratory 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 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 Planned/actual admission to the intensive care unit Pregnant or nursing women No birth control during the specified period of time Participated in clinical trials of other drugs (received experimental drugs) The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Facility Information:
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

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A Trial of HR021618 in Postsurgical Pain Management

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