A Trial of SHR0410 Injection in Postsurgical Pain Management

Phase 2TerminatedNCT05394402

Jiangsu HengRui Medicine Co., Ltd.31 enrolled

Overview

The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic Surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postsurgical Pain

Interventions

SHR0410 InjectionDRUG

SHR0410 Injection

Placebo for SHR0410 InjectionDRUG

SHR0410 Injection blank preparation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able and willing to provide a written informed consent； 2. Subjects requiring elective general anesthesia orthopedic surgery； 3. Male or female； 4. Meet the body mass index standard； 5. Conform to the ASA Physical Status Classification； 6. Negative pregnancy test. Exclusion Criteria: 1. Subjects with a history of myocardial infarction or unstable angina pectoris； 2. Subjects with atrioventricular block or cardiac insufficiency； 3. Subjects with a history of malignancy ； 4. Subjects with a history of stroke； 5. Subjects with a history of mental illness； 6. Subjects with a history of difficult airway； 7. Random blood glucose ≥11.1mmol/L； 8. Subjects with poor blood pressure control； 9. Abnormal values in liver or renal function； 10. Subject with a history of substance abuse and drug abuse； 11. Allergic to drugs that may be used during the study； 12. 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； 13. Participated in clinical trials of other drugs (received experimental drugs)； 14. Other circumstances that the investigator judged inappropriate for participation in this clinical trial.

Locations (1)

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Outcomes

Primary Outcomes

Usage of Morphine, Post Surgery

Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 48 hour period post IP administration

Time frame: 0 hour to 48 hours after IP administration

Secondary Outcomes

Usage of Morphine, Post Surgery at other intervals

Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-24 hours after IP administration.Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 4-48 hours after IP administration.

Time frame: 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration

the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under static condition

Pain intensity will be evaluated using an 11-point (0-10) Numeric Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NRS.

Time frame: 48-hours

the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition

Time frame: 48-hours

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.

Data from ClinicalTrials.gov

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