A Trial of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal

NCT04852003 | Completed Phase 3

• 1 other identifier: SHR0410-301
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after endoscopic surgery of the lower abdominal.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• The area under the curve of pain intensity over 24 hours

  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 24 hours.

  24-hours

Secondary Outcomes (6)

• Total consumption of remedial analgesics from 0h to 24h

  24-hours

• Participant ' satisfaction score for analgesia treatment

  24-hours

• Investigator satisfaction score for analgesia treatment

  24-hours

• Frequency and severity of adverse events

  Day 4（or early termination on Day 3）

• Safety as assessed by vital signs

  Day 4（or early termination on Day 3）

Study Arms (3)

SHR0410 Injection

EXPERIMENTAL

Drug: SHR0410 Injection

Placebo for SHR0410 Injection

PLACEBO COMPARATOR

Drug: Placebo

Morphine

ACTIVE COMPARATOR

Drug: Morphine

Interventions

SHR0410 Injection DRUG

SHR0410 Injection

SHR0410 Injection

Placebo DRUG

Placebo for SHR0410 Injection

Placebo for SHR0410 Injection

Morphine DRUG

Morphine

Morphine

Eligibility Criteria

• Age: 18 Years - 65 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 endoscopic surgery of the lower abdominal
• Male or female
• Meet the body mass index standard
• Conform to the ASA Physical Status Classification

You may not qualify if:

• Subjects with a history of difficult airway
• Subjects with a history of mental illness
• Subjects with a history of cognitive impairment epilepsy
• Subjects with a history of myocardial infarction or unstable angina pectoris
• Subjects with atrioventricular block or cardiac insufficiency
• Subjects with a history of ischemic stroke or transient ischemic attack
• Subjects with poor blood pressure control after medication
• Subject with a history of substance abuse and drug abuse
• Abnormal values in liver function
• Subjects with an oxygen saturation below 90% on room air
• Allergic to drugs that may be used during the study
• Pregnant or nursing women
• No birth control during the specified period of time
• Participated in clinical trials of other drugs (received experimental drugs)
• The investigators 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 of Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• 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 and morphine

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 21, 2021
• Study Start: May 13, 2021
• Primary Completion: June 26, 2021
• Study Completion: July 22, 2021
• Last Updated: February 10, 2022

Record last verified: 2021-04

Locations

CN (1)