A Clinical Study of the Combination of SHR8554 Injection and SHR0410 Injection for the Treatment of Pain After Abdominal Surgery.

NCT05470049 | Unknown Phase 2

• 1 other identifier: SHR8554/SHR0410-201
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective is to evaluate the analgesic efficacy of the combination of SHR8554 injection and SHR0410 injection compared with SHR8554 injection in patients with acute postoperative pain following abdominal surgery

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• the Sum of Pain Intensity Differences in Pain Score Over 24 Hours

  Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.

  24-hours

Secondary Outcomes (5)

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

  6-hours、12-hours、12-24 hours

• Time of first use of remedial analgesic medication

  24-hours

• Cumulative use 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

Study Arms (3)

Treatment group A: SHR8554 Injection and SHR0410 Injection

EXPERIMENTAL

Drug: SHR8554 Injection and SHR0410 Injection

Treatment group B: SHR8554 Injection and SHR0410 Injection

EXPERIMENTAL

Drug: SHR8554 Injection and SHR0410 Injection

Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection

PLACEBO COMPARATOR

Drug: SHR8554 Injection and Placebo for SHR0410 Injection

Interventions

SHR8554 Injection and SHR0410 Injection DRUG

Treatment group A: SHR8554 Injection and SHR0410 Injection; high dose

Treatment group A: SHR8554 Injection and SHR0410 Injection

SHR8554 Injection and Placebo for SHR0410 Injection DRUG

Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection

Treatment group C: SHR8554 Injection and 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 abdominal surgery
• Conform to the ASA Physical Status Classification

You may not qualify if:

• Subjects with a history of difficult airway
• Subjects with a history of reflux esophagitis
• Subjects with a history of mental illness
• Subjects with poor blood pressure control
• Random blood glucose ≥11.1mmol/L
• Subjects with abnormal liver function
• allergies to opioids and other medications that may be used during the trial
• The investigators determined that other conditions were inappropriate for participation in this clinical trial

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Qin Liu

CONTACT

+0518-82342973; qin.liu@hengrui.com

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: July 20, 2022
• First Posted: July 22, 2022
• Study Start: August 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 30, 2022
• Last Updated: July 22, 2022

Record last verified: 2022-07