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A Study of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05769855
Collaborator
(none)
294
Enrollment
3
Arms
8.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: HR18034
  • Drug: ropivacaine HCl
  • Drug: Sodium Chloride Physiological Solution
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
294 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
HR18034 compared with active comparator and placeboHR18034 compared with active comparator and placebo
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Mar 30, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: HR18034

Drug: HR18034
HR18034 380mg
Active Comparator: ropivacaine HCl

Drug: ropivacaine HCl
ropivacaine HCl 75mg.
Placebo Comparator: Sodium Chloride Physiological Solution

Drug: Sodium Chloride Physiological Solution
Sodium Chloride Physiological Solution 20ml

Outcome Measures

Primary Outcome Measures

  1. AUC of Pain Intensity in rest state [0~72 hours after administration]

    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

  1. Proportion of subjects with Pain Rating Scale (NPRS)≥4 during dressing change [0~72 hours after administration]

  2. Proportion of subjects with Pain Rating Scale (NPRS)≥4 during defecation [0~72 hours after administration]

  3. AUC of Pain Intensity in rest state [0~24 hours after administration]

  4. AUC of Pain Intensity in move state [0~24 hours，0~72 hours after administration]

  5. Proportion of subjects who doesn't recive rescue analgesic [0~72 hours after administration]

  6. Participant's satisfaction score for analgesia treatment [72-hours]

  7. Investigator's satisfaction score for analgesia treatment [72-hours]

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 hemorrhoidectomy under subarachnoid anesthesia

  3. 18 kg/m2 ≤ BMI ≤ 30 kg/m2

  4. Conform to the ASA Physical Status Classification

  5. Women of childbearing age have a negative pregnancy test and are not nursing

Exclusion Criteria:

  1. Subjects with a history of myocardial infarction or unstable angina pectoris

  2. Subjects with atrioventricular block or cardiac insufficiency

  3. Subjects with a history of ischemic stroke or transient ischemic attack

  4. Subjects with a history of mental illness and a history of cognitive impairment epilepsy

  5. Subjects with concurrent painful physical condition that may affect postoperative pain assessment

  6. Spinal or spinal lesions that were determined by the investigator to be unable to tolerate subarachnoid anesthesia

  7. Subjects with a history of hemorrhoidectomy

  8. Subjects with a history of constipation

  9. Subjects with a history of perianal disease

  10. Abnormal values in the laboratory

  11. Subject with heart rate <50 or >100 beats per minute.

  12. Subject with refractory hypertension

  13. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study

  14. History of prohibited drug use

  15. Participants who may be affected by alcohol, or drug abstinence during the study period;

  16. Participated in clinical trials of other drugs (received experimental drugs)

  17. The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Hengrui Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Hengrui Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05769855
Other Study ID Numbers:
  • HR18034-301
First Posted:
Mar 15, 2023
Last Update Posted:
Mar 15, 2023
Last Verified:
Feb 1, 2023
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
Additional relevant MeSH terms:
Pain, Postoperative
Ropivacaine

Study Results

No Results Posted as of Mar 15, 2023