HR021618 in Moderate to Severe Pain After Abdominal Surgery

A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of HR021618 in the Treatment of Moderate to Severe Pain After Abdominal Surgery

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04811053

Enrollment

Registered

2021-03-23

Start date

2021-04-12

Completion date

2021-07-15

Last updated

2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain After Abdominal Surgery

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.

Interventions

DRUGHR021618

Treatment group A: HR021618 injection

DRUGPlacebo

Treatment group B: Saline injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
AUC48	48 hours after recovery from anesthesia] Area under the pain intensity-time curve.	Area under the pain intensity-time curve.

Secondary

Measure	Time frame	Description
AUC3, AUC24, AUC15-21, AUC18-24, AUC24-28, AUC39-45, AUC42-48	48 hours after recovery from anesthesia	Area under the pain intensity-time curve.
Time of the first dose of rescue analgesia	48 hours after recovery from anesthesia	Time of the first dose of rescue analgesia after recovery from anesthesia.
Proportion of subjects receiving rescue analgesia	48 hours after recovery from anesthesia	Proportion of subjects receiving rescue analgesia after recovery from anesthesia.
Total consumption of morphine over 0-48, 0-24, 24-48 hours	48 hours after recovery from anesthesia	Total consumption of morphine after recovery from anesthesia.
Subjects' satisfaction rating	48 hours after recovery from anesthesia	Subjects' satisfaction rating.
Anesthesiologist satisfaction rating	48 hours after recovery from anesthesia	Anesthesiologist satisfaction rating.
Frequency of doses of rescue analgesia	48 hours after recovery from anesthesia	Frequency of doses of rescue analgesia after recovery from anesthesia.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026