A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery

July 12, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Phase Ⅲ, Randomized, Double-blind, Placebo-controlled Study of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery

The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after laparoscopic surgery

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
357

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Able and willing to provide a written informed consent
  2. Subjects requiring elective general anesthesia endoscopic surgery of the lower abdominal
  3. Male or female
  4. Meet the body mass index standard
  5. Conform to the ASA Physical Status Classification

Exclusion Criteria:

  1. Subjects with a history of difficult airway
  2. Subjects with a history of mental illness
  3. Subjects with a history of cognitive impairment epilepsy
  4. Subjects with a history of myocardial infarction or unstable angina pectoris
  5. Subjects with atrioventricular block or cardiac insufficiency
  6. Subjects with a history of ischemic stroke or transient ischemic attack
  7. Subjects with poor blood pressure control after medication
  8. Subject with a history of substance abuse and drug abuse
  9. Abnormal values in liver function
  10. Allergic to drugs that may be used during the study
  11. Pregnant or nursing women
  12. No birth control during the specified period of time
  13. Participated in clinical trials of other drugs (received experimental drugs)
  14. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment group A
SHR0410 Injection（Low Dose）
Drug: SHR0410 Injection
SHR0410 Injection（Low Dose）
Drug: SHR0410 Injection
SHR0410 Injection（High Dose）
Experimental: Treatment group B
SHR0410 Injection（High Dose）
Drug: SHR0410 Injection
SHR0410 Injection（Low Dose）
Drug: SHR0410 Injection
SHR0410 Injection（High Dose）
Placebo Comparator: Treatment group C
Placebo for SHR0410 Injection.
Drug: Placebo
Placebo for SHR0410 Injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Summed Pain Intensity Difference From 0-24 Hours (SPID0-24)
Time Frame: 0 to 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.
0 to 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Summed Pain Intensity Difference Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours (SPID2、SPID4、SPID6、 SPID12、SPID18)
Time Frame: 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours
Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity.
0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours
Estimated Time From The Start Of The Infusion Of Study Drug To The First NRS reaching 3 or less
Time Frame: 0 to 24 hours
0 to 24 hours
Total Pain Relief Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours、24 Hours
Time Frame: 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours、0 to 24 hours
Patients reported their pain relief using a 5-point(0-4) categorical scale (PR), with "0" indicating "No Relief", "1" indicating "A Little Relief", "2" indicating "Some Relief ", "3" indicating "A Lot of Relief" and "4" indicating "Complete Relief".
0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours、0 to 24 hours
Total consumption of remedial analgesics from 0 to 24 hours
Time Frame: 24-hours
24-hours
Participant' Satisfaction Score For Analgesia Treatment
Time Frame: 24-hours
24-hours
Investigator Satisfaction Score For Analgesia Treatment
Time Frame: 24-hours
24-hours
Numbers of Participants With Abnormal Vital Signs
Time Frame: Day 3 or Day 4
Changes in vital signs such as body temperature (using the celsius system) will be assessed at specified times.
Day 3 or Day 4
Numbers of Participants With Abnormal Vital Signs
Time Frame: Day 3 or Day 4
Changes in vital signs such as, blood pressure (using mmHg) will be assessed at specified times.
Day 3 or Day 4
Numbers of Participants With Abnormal Vital Signs
Time Frame: Day 3 or Day 4
Changes in vital signs such as , heart rate (measured by beats per minute) will be assessed at specified times.
Day 3 or Day 4
Numbers of Participants With Abnormal Laboratory Values
Time Frame: Day 3 or Day 4
Participants with clinically significant lab values will be compared to those receiving placebo comparator.
Day 3 or Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR0410-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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