HR021618 in Moderate to Severe Pain After Abdominal Surgery

NCT04811053 | Completed Phase 2

• 1 other identifier: HR021618-203
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain After Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• AUC48

  Area under the pain intensity-time curve.

  48 hours after recovery from anesthesia] Area under the pain intensity-time curve.

Secondary Outcomes (7)

• Total consumption of morphine over 0-48, 0-24, 24-48 hours

  48 hours after recovery from anesthesia

• AUC3, AUC24, AUC15-21, AUC18-24, AUC24-28, AUC39-45, AUC42-48

  48 hours after recovery from anesthesia

• Time of the first dose of rescue analgesia

  48 hours after recovery from anesthesia

• Proportion of subjects receiving rescue analgesia

  48 hours after recovery from anesthesia

• Frequency of doses of rescue analgesia

  48 hours after recovery from anesthesia

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: HR021618

Treatment group B

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HR021618 DRUG

Treatment group A: HR021618 injection

Treatment group A

Placebo DRUG

Treatment group B: Saline injection

Treatment group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• Subjects requiring elective general anesthesia abdominal surgery
• Male or female
• Meet BMI standard
• Conform to the ASA Physical Status Classification

You may not qualify if:

• Subjects with a history of abdominal surgery
• Subjects had hemorrhagic disorders
• Subjects had cardiac, serious hepatic or renal, cardiovascular or cerebrovascular, metabolic, psychiatric disorders, chronic pain, or malignant tumors
• Subjects with poor blood pressure control after medication
• Abnormal QTc
• Abnormal random blood glucose
• Abnormal values in the laboratory
• 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
• 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
• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: April 12, 2021
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

CN (1)