Inguinal Hernia Repair
Conditions
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®
Interventions
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
To maintain objectiveness, the study drug will be managed and administered by an independent unblinded team. Subjects, investigators, and all other site staff who directly interact with subjects, evaluate safety and efficacy, and collect subject data, will remain blinded and must not communicate or discuss any study information with the unblinded team.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of SAEs and treatment-related severe AEs | 14 days | Safety and tolerability: |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC of NPRS | For time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours | AUC of NPRS for time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours |
| Patient Global Assessment of the method of pain control | 24 hours post IP administration till 168 hours post IP administration | 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. |
| Proportion of pain-free subjects at scheduled timepoints. | Baseline till 168 hours post IP administration | Pain-free defined as an NPRS of 0 or 1 |
| Proportion of subjects who used no rescue opioid analgesic | Baseline till 168 hours post IP administration | Proportion of subjects who used no rescue opioid analgesic |
| Pain intensity assessed using an 11-point NPRS ranging | Baseline till 168 hours post IP administration | 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 |
| Time to the first postoperative use of rescue opioid analgesics | Baseline till 168 hours post IP administration | Time to the first postoperative use of rescue opioid analgesics |
| PK Cmax | Baseline till 168 hours post IP administration | Maximum blood concentration (Cmax) |
| Wound assessment by Wound healing and status score | Day 1 through Day 14 | 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. |
| PK AUC | Baseline till 168 hours post IP administration | Area under the blood concentration-time curve (AUC) |
| Average daily rescue analgesic consumption | Baseline till 168 hours post IP administration | Average daily rescue analgesic consumption through 24, 48, 72 and 96 hours |
Countries
China
Contacts
Primary ContactWeidong Mi, PhD
Outcome results
None listed