HR021618 in Moderate to Severe Pain After Abdominal Surgery

NCT ID: NCT04811053

Last Updated: 2025-05-15

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2021-07-15

Brief Summary

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The study is being conducted to evaluate the efficacy and safety of HR021618 in the treatment of moderate to severe pain after abdominal surgery.

Detailed Description

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Conditions

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Pain After Abdominal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
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 injection

Treatment group B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Treatment group B: Saline injection

Interventions

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HR021618

Treatment group A: HR021618 injection

Intervention Type DRUG

Placebo

Treatment group B: Saline injection

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 general anesthesia abdominal surgery
3. Male or female
4. Meet BMI standard
5. Conform to the ASA Physical Status Classification

Exclusion Criteria

1. Subjects with a history of abdominal surgery
2. Subjects had hemorrhagic disorders
3. Subjects had cardiac, serious hepatic or renal, cardiovascular or cerebrovascular, metabolic, psychiatric disorders, chronic pain, or malignant tumors
4. Subjects with poor blood pressure control after medication
5. Abnormal QTc
6. Abnormal random blood glucose
7. Abnormal values in the laboratory
8. Allergic 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
9. 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
10. Pregnant or nursing women
11. No birth control during the specified period of time
12. Participated in clinical trials of other drugs (received experimental drugs)
13. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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HR021618-203

Identifier Type: -

Identifier Source: org_study_id

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