A Trial of SHR0410 Injection in Postsurgical Pain Management

NCT05394402 | Terminated Phase 2

• 1 other identifier: SHR0410-202
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postsurgical Pain

Outcome Measures

Primary Outcomes (1)

• 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

  0 hour to 48 hours after IP administration

Secondary Outcomes (9)

• Usage of Morphine, Post Surgery at other intervals

  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

  48-hours

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

  48-hours

• Time to First Dose of Rescue Analgesia

  0 hour to 48 hours after IP administration

• Frequency of Doses of Rescue Analgesia Utilized Per Subject， total consumption of morphine Rescue Analgesia Utilized Per Subject

  0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration

Study Arms (3)

SHR0410 Injection High dose

EXPERIMENTAL

Drug: SHR0410 Injection

SHR0410 Injection Low dose

EXPERIMENTAL

Drug: SHR0410 Injection

Placebo for SHR0410 Injection

PLACEBO COMPARATOR

Drug: Placebo for SHR0410 Injection

Interventions

SHR0410 Injection DRUG

SHR0410 Injection

SHR0410 Injection High dose; SHR0410 Injection Low dose

Placebo for SHR0410 Injection DRUG

SHR0410 Injection blank preparation

Placebo for SHR0410 Injection

Eligibility Criteria

• Age: 18 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 orthopedic surgery；
• Male or female；
• Meet the body mass index standard；
• Conform to the ASA Physical Status Classification；
• Negative pregnancy test.

You may not qualify if:

• Subjects with a history of myocardial infarction or unstable angina pectoris；
• Subjects with atrioventricular block or cardiac insufficiency；
• Subjects with a history of malignancy ；
• Subjects with a history of stroke；
• Subjects with a history of mental illness；
• Subjects with a history of difficult airway；
• Random blood glucose ≥11.1mmol/L；
• Subjects with poor blood pressure control；
• Abnormal values in liver or renal function；
• Subject with a history of substance abuse and drug abuse；
• Allergic to drugs that may be used during the 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；
• Participated in clinical trials of other drugs (received experimental drugs)；
• Other circumstances that the investigator judged inappropriate for participation in this clinical trial.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

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

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

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: SHR0410 Injection compared with placebo

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: August 9, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 22, 2025

Record last verified: 2025-05

Locations

CN (1)