Clincosm LogoSign in Get a demo

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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05470049
Collaborator
(none)
108
Enrollment
3
Arms
4
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: SHR8554 Injection and SHR0410 Injection
  • Drug: SHR8554 Injection and SHR0410 Injection
  • Drug: SHR8554 Injection and Placebo for SHR0410 Injection
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel AssignmentParallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase II, Randomized, Double-Blind Study of the Combination of SHR8554 Injection and SHR0410 Injection for the Treatment of Pain After Abdominal Surgery.
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group A: SHR8554 Injection and SHR0410 Injection

Drug: SHR8554 Injection and SHR0410 Injection
Treatment group A: SHR8554 Injection and SHR0410 Injection; high dose
Experimental: Treatment group B: SHR8554 Injection and SHR0410 Injection

Drug: SHR8554 Injection and SHR0410 Injection
Treatment group B: SHR8554 Injection and SHR0410 Injection; low dose
Placebo Comparator: Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection

Drug: SHR8554 Injection and Placebo for SHR0410 Injection
Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection

Outcome Measures

Primary Outcome Measures

  1. the Sum of Pain Intensity Differences in Pain Score Over 24 Hours [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.

Secondary Outcome Measures

  1. the Sum of Pain Intensity Differences in Pain Score Over 6、12、12-24 Hours [6-hours、12-hours、12-24 hours]

    time weighted sum of pain intensity differences (SPID) divided by a constant (6、12、12-24 hours) to yield values on the 0-10 NPRS.

  2. Time of first use of remedial analgesic medication [24-hours]

    The first time to use remedial analgesic medication for injection

  3. Cumulative use of remedial analgesics from 0h to 24h [24-hours]

    Cumulative use of remedial analgesic medication

  4. Participant ' satisfaction score for analgesia treatment [24-hours]

    Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 0 to 10, with 0 representing dissatisfied and 10 representing very satisfied.

  5. Investigator satisfaction score for analgesia treatment [24-hours]

    Postoperative analgesia was evaluated by investigators.The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Able and willing to provide a written informed consent

  2. Subjects requiring elective general anesthesia abdominal surgery

  3. Conform to the ASA Physical Status Classification

Exclusion Criteria:

  1. Subjects with a history of difficult airway

  2. Subjects with a history of reflux esophagitis

  3. Subjects with a history of mental illness

  4. Subjects with poor blood pressure control

  5. Random blood glucose ≥11.1mmol/L

  6. Subjects with abnormal liver function

  7. allergies to opioids and other medications that may be used during the trial

  8. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05470049
Other Study ID Numbers:
  • SHR8554/SHR0410-201
First Posted:
Jul 22, 2022
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 22, 2022