A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05376904
• Collaborator: (none)
• Enrollment: 84
• Arms: 4
• Anticipated Duration (Months): 10

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. To explore the reasonable dosage of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.

Condition or Disease	Intervention/Treatment	Phase
Postsurgical Pain Management	Drug: HR18034; Drug: HR18034; Drug: HR18034; Drug: ropivacaine HCl.	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: HR18034 compared with active comparatorHR18034 compared with active comparator
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jun 1, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HR18034 dose 1	Drug: HR18034; HR18034 low dose
Experimental: HR18034 dose 2	Drug: HR18034; HR18034 midium dose
Experimental: HR18034 dose 3	Drug: HR18034; HR18034 high dose
Active Comparator: ropivacaine HCl	Drug: ropivacaine HCl.; ropivacaine HCl.

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. AUC of Pain Intensity in rest state [0~24 hours，0~48 hours after administration]

   AUC of Pain Intensity in rest state

2. AUC of Pain Intensity in move state [0~24 hours，0~48 hours，0~72 hours after administration]

   AUC of Pain Intensity in move state

3. Pain intensity in rest state assessed using an 11-point NPRS ranging [0~72 hours after administration]

   11-point NPRS ranging from a score of 0 to 10

4. Pain intensity in move state assessed using an 11-point NPRS ranging [0~72 hours after administration]

   11-point NPRS ranging from a score of 0 to 10

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 ≤ 28 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. Subjects with myelopathy or spinal disease

7. Subjects with a history of hemorrhoidectomy

8. Abnormal values in the laboratory

9. Subject with a history of substance abuse and drug abuse

10. Subject with refractory hypertension

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

12. History of substance abuse, drug use and/or alcohol abuse

13. HBsAg, HCVAb, HIV antibody and syphilis antibody tested positive during screening period;

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

15. 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: NCT05376904
• Other Study ID Numbers: HR18034-202
• First Posted: May 17, 2022
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• 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 May 17, 2022