A Trial of HR021618 in Postsurgical Pain Management

NCT ID: NCT04699175

Last Updated: 2021-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-17

Study Completion Date

2021-08-08

Brief Summary

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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

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Conditions

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Postsurgical Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

HR021618 compared with placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group A

Group Type EXPERIMENTAL

HR021618

Intervention Type DRUG

Treatment group A:HR021618; high dose

Treatment group B

Group Type EXPERIMENTAL

HR021618

Intervention Type DRUG

Treatment group B:HR021618; low dose

Treatment group C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Treatment group C: HR021618 blank preparation.

Interventions

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HR021618

Treatment group A:HR021618; high dose

Intervention Type DRUG

HR021618

Treatment group B:HR021618; low dose

Intervention Type DRUG

Placebo

Treatment group C: HR021618 blank preparation.

Intervention Type DRUG

Eligibility Criteria

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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

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


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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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HR021618-202

Identifier Type: -

Identifier Source: org_study_id

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