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A Study of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Primary Purpose

Postsurgical Pain Management

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HR18034
ropivacaine HCl
Sodium Chloride Physiological Solution
Sponsored by
Shanghai Hengrui Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postsurgical Pain Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Able and willing to provide a written informed consent Subjects requiring hemorrhoidectomy under subarachnoid anesthesia 18 kg/m2 ≤ BMI ≤ 30 kg/m2 Conform to the ASA Physical Status Classification Women of childbearing age have a negative pregnancy test and are not nursing Exclusion Criteria: 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 a history of mental illness and a history of cognitive impairment epilepsy Subjects with concurrent painful physical condition that may affect postoperative pain assessment Spinal or spinal lesions that were determined by the investigator to be unable to tolerate subarachnoid anesthesia Subjects with a history of hemorrhoidectomy Subjects with a history of constipation Subjects with a history of perianal disease Abnormal values in the laboratory Subject with heart rate <50 or >100 beats per minute. Subject with refractory hypertension History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study History of prohibited drug use Participants who may be affected by alcohol, or drug abstinence during the study period; Participated in clinical trials of other drugs (received experimental drugs) The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Sites / Locations

  • The Third Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

HR18034

ropivacaine HCl

Sodium Chloride Physiological Solution

Arm Description

Outcomes

Primary Outcome Measures

AUC of Pain Intensity in rest state
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 72 hours.

Secondary Outcome Measures

Proportion of subjects with Pain Rating Scale (NPRS)≥4 during dressing change
Proportion of subjects with Pain Rating Scale (NPRS)≥4 during defecation
AUC of Pain Intensity in rest state
AUC of Pain Intensity in move state
Proportion of subjects who doesn't recive rescue analgesic
Participant's satisfaction score for analgesia treatment
Investigator's satisfaction score for analgesia treatment

Full Information

First Posted
March 3, 2023
Last Updated
March 23, 2023
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05769855
Brief Title
A Study of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Evaluate the Efficacy and Safety of Local Administration of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postsurgical Pain Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
HR18034 compared with active comparator and placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
294 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HR18034
Arm Type
Experimental
Arm Title
ropivacaine HCl
Arm Type
Active Comparator
Arm Title
Sodium Chloride Physiological Solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HR18034
Intervention Description
HR18034 380mg
Intervention Type
Drug
Intervention Name(s)
ropivacaine HCl
Intervention Description
ropivacaine HCl 75mg.
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride Physiological Solution
Intervention Description
Sodium Chloride Physiological Solution 20ml
Primary Outcome Measure Information:
Title
AUC of Pain Intensity in rest state
Description
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 72 hours.
Time Frame
0~72 hours after administration
Secondary Outcome Measure Information:
Title
Proportion of subjects with Pain Rating Scale (NPRS)≥4 during dressing change
Time Frame
0~72 hours after administration
Title
Proportion of subjects with Pain Rating Scale (NPRS)≥4 during defecation
Time Frame
0~72 hours after administration
Title
AUC of Pain Intensity in rest state
Time Frame
0~24 hours after administration
Title
AUC of Pain Intensity in move state
Time Frame
0~24 hours,0~72 hours after administration
Title
Proportion of subjects who doesn't recive rescue analgesic
Time Frame
0~72 hours after administration
Title
Participant's satisfaction score for analgesia treatment
Time Frame
72-hours
Title
Investigator's satisfaction score for analgesia treatment
Time Frame
72-hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able and willing to provide a written informed consent Subjects requiring hemorrhoidectomy under subarachnoid anesthesia 18 kg/m2 ≤ BMI ≤ 30 kg/m2 Conform to the ASA Physical Status Classification Women of childbearing age have a negative pregnancy test and are not nursing Exclusion Criteria: 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 a history of mental illness and a history of cognitive impairment epilepsy Subjects with concurrent painful physical condition that may affect postoperative pain assessment Spinal or spinal lesions that were determined by the investigator to be unable to tolerate subarachnoid anesthesia Subjects with a history of hemorrhoidectomy Subjects with a history of constipation Subjects with a history of perianal disease Abnormal values in the laboratory Subject with heart rate <50 or >100 beats per minute. Subject with refractory hypertension History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study History of prohibited drug use Participants who may be affected by alcohol, or drug abstinence during the study period; Participated in clinical trials of other drugs (received experimental drugs) The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qin Liu
Phone
+0518-82342973
Email
qin.liu@hengrui.com
Facility Information:
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yangwen Ou

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Study of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

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