A Trial of HR18034 in Inguinal Hernia Repair

Inguinal Hernia Repair Clinical Trial

Official title:

A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of HR18034 for Pain Management After Inguinal Hernia Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04551924
• Other study ID #: HR18034-101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: September 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Weidong Mi, PhD
• Phone: 010-66937116
• Email: wwdd1962[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase I, randomized, double-blind, comparator-controlled study to assess the safety, PK, and efficacy of single postsurgical application of HR18034 compared with Naropin®

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Able and willing to provide a written informed consent 2?Male or female between 18 and 70 years of age 3?Scheduled to undergo a primary, inguinal hernia repair with mesh, and be able to use the anesthesia regimen 4?Meet the body mass 5?Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Clinically significant abnormal clinical laboratory test value

2. Subjects with poor blood pressure control after medication

3. Subjects with atrioventricular block or cardiac insufficiency

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

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

6. Combination of other pain conditions that may affect postoperative pain assessment

7. Allergic to a drug ingredient or component

8. Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer

9. History of alcohol abuse or prescription and/or illicit drug abuse within 1 years

10. Subjects with special diets (including tobacco, grapefruit and caffeine)

11. Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.

12. History of human immunodeficiency virus (HIV), hepatitis C, syphilis antibody,or hepatitis B.

13. Use of any of the following medications within 14 days or as specified prior to the study surgical procedure:

14. Have had an inguinal hernia repair in the last 3 months before the study surgical procedure or presents with bilateral or recurrent inguinal hernia, other hernia presentations, or hernias with a large scrotal component that would be difficult to reduce surgically

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

16. History or clinical manifestations of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition.

17. Pregnant or nursing women

18. No birth control during the specified period of time

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia Repair

Intervention

Drug:
• HR18034
HR18034(Ropivacaine Liposome for Injection) is a sustained-release liposome
• Naropin
Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg [0.5%, 5mg/mL] x 30mL

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of SAEs and treatment-related severe AEs	Safety and tolerability:	14 days
Secondary	Pain intensity assessed using an 11-point NPRS ranging	11-point Numercal Pain Rating Scale ranging from a score of 0 to 10. Pain-free defined as an NPRS of 0 or 1. Worst imaginable pain defined as an NPRS of 10	Baseline till 168 hours post IP administration
Secondary	AUC of NPRS	AUC of NPRS for time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours	For time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours
Secondary	Patient Global Assessment of the method of pain control	Patient Global Assessment ranging from a score of 0 to 10. Satisfaction defined as a scale of 10, dissatisfaction defined as a scale of 0.	24 hours post IP administration till 168 hours post IP administration
Secondary	Proportion of pain-free subjects at scheduled timepoints.	Pain-free defined as an NPRS of 0 or 1	Baseline till 168 hours post IP administration
Secondary	Proportion of subjects who used no rescue opioid analgesic	Proportion of subjects who used no rescue opioid analgesic	Baseline till 168 hours post IP administration
Secondary	Average daily rescue analgesic consumption	Average daily rescue analgesic consumption through 24, 48, 72 and 96 hours	Baseline till 168 hours post IP administration
Secondary	Time to the first postoperative use of rescue opioid analgesics	Time to the first postoperative use of rescue opioid analgesics	Baseline till 168 hours post IP administration
Secondary	PK Cmax	Maximum blood concentration (Cmax)	Baseline till 168 hours post IP administration
Secondary	Wound assessment by Wound healing and status score	The surgical site will be examined by the investigator using Wound healing and status score. Wound healing and status score ranging from a score of 0 to 4,Good defined as a scale of 0. Worst defined as a scale of 4.	Day 1 through Day 14
Secondary	PK AUC	Area under the blood concentration-time curve (AUC)	Baseline till 168 hours post IP administration