A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.
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
1 other identifier
interventional
86
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2022
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2022
CompletedFirst Posted
Study publicly available on registry
May 17, 2022
CompletedStudy Start
First participant enrolled
June 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2022
CompletedMarch 20, 2023
May 1, 2022
4 months
May 11, 2022
March 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
0~72 hours after administration
Secondary Outcomes (7)
AUC of Pain Intensity in rest state
0~24 hours，0~48 hours after administration
AUC of Pain Intensity in move state
0~24 hours，0~48 hours，0~72 hours after administration
Pain intensity in rest state assessed using an 11-point NPRS ranging
0~72 hours after administration
Pain intensity in move state assessed using an 11-point NPRS ranging
0~72 hours after administration
Proportion of subjects who doesn't recive rescue analgesic
0~72 hours after administration
- +2 more secondary outcomes
Study Arms (4)
HR18034 dose 1
EXPERIMENTALHR18034 dose 2
EXPERIMENTALHR18034 dose 3
EXPERIMENTALropivacaine HCl
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Able and willing to provide a written informed consent
- Subjects requiring hemorrhoidectomy under subarachnoid anesthesia
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100005, China
Dongguan people's Hospital
Dongguan, Guangdong, 523000, China
Nanning Second People's Hospital
Nanning, Guangxi, 530000, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000, China
Traditional Chinese Medicine Hospital of Hebei Province
Shijiazhuang, Hebei, 050000, China
Shiyan Taihe Hospital
Shiyan, Hubei, 442099, China
the first People's Hospital of Changde
Changde, Hunan, 415000, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
Taizhou People's Hospital
Taizhou, Jiangsu, 225300, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110000, China
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250000, China
the First Affiliated Hospital of Xi'An Jiaotong University
Xi’an, Shanxi, 710061, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, 710077, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
Jiaxing Second Hospital
Jiaxing, Zhejiang, 314000, China
Li Huili Hospital of Ningbo Medical Center
Ningbo, Zhejiang, 315040, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
Study Record Dates
First Submitted
May 11, 2022
First Posted
May 17, 2022
Study Start
June 13, 2022
Primary Completion
October 5, 2022
Study Completion
October 5, 2022
Last Updated
March 20, 2023
Record last verified: 2022-05