Clinical trial NCT04551924: A Trial of HR18034 in Inguinal Hernia Repair
Official title: A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of HR18034 for Pain Management After Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Inguinal Hernia Repair
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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®


Eligibility criteria: 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

Primary outcomes:
measure: Number of SAEs and treatment-related severe AEs
timeFrame: 14 days
Secondary outcomes:
measure: Pain intensity assessed using an 11-point NPRS ranging
timeFrame: Baseline till 168 hours post IP administration
measure: AUC of NPRS
timeFrame: For time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours
measure: Patient Global Assessment of the method of pain control
timeFrame: 24 hours post IP administration till 168 hours post IP administration
measure: Proportion of pain-free subjects at scheduled timepoints.
timeFrame: Baseline till 168 hours post IP administration
measure: Proportion of subjects who used no rescue opioid analgesic
timeFrame: Baseline till 168 hours post IP administration
measure: Average daily rescue analgesic consumption
timeFrame: Baseline till 168 hours post IP administration
measure: Time to the first postoperative use of rescue opioid analgesics
timeFrame: Baseline till 168 hours post IP administration
measure: PK Cmax
timeFrame: Baseline till 168 hours post IP administration
measure: Wound assessment by Wound healing and status score
timeFrame: Day 1 through Day 14
measure: PK AUC
timeFrame: Baseline till 168 hours post IP administration
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Weidong Mi, PhD
role: PRINCIPAL_INVESTIGATOR
References: