Back to resultsA Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.
Primary Purpose
Postsurgical Pain Management
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HR18034
HR18034
HR18034
ropivacaine HCl.
Sponsored by
About this trial
This is an interventional treatment trial for Postsurgical Pain Management
Eligibility Criteria
Inclusion Criteria:
- Able and willing to provide a written informed consent
- Subjects requiring hemorrhoidectomy under subarachnoid anesthesia
- 18 kg/m2 ≤ BMI ≤ 28 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
- Subjects with myelopathy or spinal disease
- Subjects with a history of hemorrhoidectomy
- Abnormal values in the laboratory
- Subject with a history of substance abuse and drug abuse
- 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 substance abuse, drug use and/or alcohol abuse
- HBsAg, HCVAb, HIV antibody and syphilis antibody tested positive during screening 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 Second Affiliated Hospital of Anhui Medical University
- Beijing Tongren Hospital Affiliated to Capital Medical University
- Dongguan people's Hospital
- Nanning Second People's Hospital
- The Affiliated Hospital of Guizhou Medical University
- Traditional Chinese Medicine Hospital of Hebei Province
- Shiyan Taihe Hospital
- the first People's Hospital of Changde
- The Third Xiangya Hospital of Central South University
- Taizhou People's Hospital
- Affiliated Zhongshan Hospital of Dalian University
- General Hospital of Northern Theater Command
- Central Hospital Affiliated to Shandong First Medical University
- the First Affiliated Hospital of Xi'An Jiaotong University
- The First Affiliated Hospital of Xi'an Medical University
- Sichuan Provincial People's Hospital
- Jiaxing Second Hospital
- Li Huili Hospital of Ningbo Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
HR18034 dose 1
HR18034 dose 2
HR18034 dose 3
ropivacaine HCl
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
AUC of Pain Intensity in rest state
AUC of Pain Intensity in rest state
AUC of Pain Intensity in move state
AUC of Pain Intensity in move state
Pain intensity in rest state assessed using an 11-point NPRS ranging
11-point NPRS ranging from a score of 0 to 10
Pain intensity in move state assessed using an 11-point NPRS ranging
11-point NPRS ranging from a score of 0 to 10
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
NCT ID
NCT05376904
First Posted
May 11, 2022
Last Updated
March 16, 2023
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05376904
Brief Title
A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.
Official Title
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-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
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
October 5, 2022 (Actual)
Study Completion Date
October 5, 2022 (Actual)
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. To explore the reasonable dosage 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 2
Interventional Study Model
Parallel Assignment
Model Description
HR18034 compared with active comparator
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HR18034 dose 1
Arm Type
Experimental
Arm Title
HR18034 dose 2
Arm Type
Experimental
Arm Title
HR18034 dose 3
Arm Type
Experimental
Arm Title
ropivacaine HCl
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
HR18034
Intervention Description
HR18034 low dose
Intervention Type
Drug
Intervention Name(s)
HR18034
Intervention Description
HR18034 midium dose
Intervention Type
Drug
Intervention Name(s)
HR18034
Intervention Description
HR18034 high dose
Intervention Type
Drug
Intervention Name(s)
ropivacaine HCl.
Intervention Description
ropivacaine HCl.
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
AUC of Pain Intensity in rest state
Description
AUC of Pain Intensity in rest state
Time Frame
0~24 hours，0~48 hours after administration
Title
AUC of Pain Intensity in move state
Description
AUC of Pain Intensity in move state
Time Frame
0~24 hours，0~48 hours，0~72 hours after administration
Title
Pain intensity in rest state assessed using an 11-point NPRS ranging
Description
11-point NPRS ranging from a score of 0 to 10
Time Frame
0~72 hours after administration
Title
Pain intensity in move state assessed using an 11-point NPRS ranging
Description
11-point NPRS ranging from a score of 0 to 10
Time Frame
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 ≤ 28 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
Subjects with myelopathy or spinal disease
Subjects with a history of hemorrhoidectomy
Abnormal values in the laboratory
Subject with a history of substance abuse and drug abuse
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 substance abuse, drug use and/or alcohol abuse
HBsAg, HCVAb, HIV antibody and syphilis antibody tested positive during screening 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
Facility Information:
Facility Name
The Second Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Facility Name
Beijing Tongren Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Facility Name
Dongguan people's Hospital
City
Dongguan
State/Province
Guangdong
ZIP/Postal Code
523000
Country
China
Facility Name
Nanning Second People's Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530000
Country
China
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550000
Country
China
Facility Name
Traditional Chinese Medicine Hospital of Hebei Province
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Name
Shiyan Taihe Hospital
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442099
Country
China
Facility Name
the first People's Hospital of Changde
City
Changde
State/Province
Hunan
ZIP/Postal Code
415000
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Facility Name
Taizhou People's Hospital
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225300
Country
China
Facility Name
Affiliated Zhongshan Hospital of Dalian University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116001
Country
China
Facility Name
General Hospital of Northern Theater Command
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Facility Name
Central Hospital Affiliated to Shandong First Medical University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China
Facility Name
the First Affiliated Hospital of Xi'An Jiaotong University
City
Xi'An
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710077
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
Jiaxing Second Hospital
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314000
Country
China
Facility Name
Li Huili Hospital of Ningbo Medical Center
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315040
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.
We'll reach out to this number within 24 hrs