Inguinal Hernia RepairPhase 1NCT04551924
A Trial of HR18034 in Inguinal Hernia Repair
A Phase 1 study testing HR18034 and Naropin in people with Inguinal Hernia Repair, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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® Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inguinal Hernia Repair
- What is being tested?
- HR18034 and Naropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 30 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Clinically significant abnormal clinical laboratory test value
- Subjects with poor blood pressure control after medication
- Subjects with atrioventricular block or cardiac insufficiency
- Subjects with a history of myocardial infarction or unstable angina pectoris
- Subjects with a history of ischemic stroke or transient ischemic attack
- Combination of other pain conditions that may affect postoperative pain assessment
Show all 19Show fewer
- Allergic to a drug ingredient or component
- Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer
- History of alcohol abuse or prescription and/or illicit drug abuse within 1 years
- Subjects with special diets (including tobacco, grapefruit and caffeine)
- Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
- History of human immunodeficiency virus (HIV), hepatitis C, syphilis antibody，or hepatitis B.
- Use of any of the following medications within 14 days or as specified prior to the study surgical procedure:
- 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
- Participated in clinical trials of other drugs (received experimental drugs)
- History or clinical manifestations of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition.
- Pregnant or nursing women
- No birth control during the specified period of time
- The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Weidong Mi, PhD, 010-66937116, wwdd1962@aliyun.com
About this study
Official title: A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of HR18034 for Pain Management After Inguinal Hernia Repair
Phase I, randomized, double-blind, comparator-controlled study to assess the safety, PK, and efficacy of single postsurgical application of HR18034 compared with Naropin®
- Conditions
- Inguinal Hernia Repair
- Being tested
- HR18034, Naropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR18034Drug
Also called subjects will receive HR18034.
HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome
NaropinDrug
Also called Naropin, 0.5% Injectable Solution
Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg [0.5%, 5mg/mL] x 30mL
| Study group | Role | What they receive |
|---|---|---|
| dose 1 | Experimental | HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome Receives: Drug: HR18034 |
| dose 2 | Experimental | HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome Receives: Drug: HR18034 |
| dose 3 | Experimental | HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome Receives: Drug: HR18034 |
| dose 4 | Experimental | HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome Receives: Drug: HR18034 |
| Naropin | Active comparator | Naronpin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial Receives: Drug: Naropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of SAEs and treatment-related severe AEs
Safety and tolerability:
Measured: 14 days
Secondary outcomes (10)
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
Measured: Baseline till 168 hours post IP administration
AUC of NPRS
AUC of NPRS for time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours
Measured: 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
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.
Measured: 24 hours post IP administration till 168 hours post IP administration
Proportion of pain-free subjects at scheduled timepoints.
Pain-free defined as an NPRS of 0 or 1
Measured: Baseline till 168 hours post IP administration
Proportion of subjects who used no rescue opioid analgesic
Proportion of subjects who used no rescue opioid analgesic
Measured: Baseline till 168 hours post IP administration
Average daily rescue analgesic consumption
Average daily rescue analgesic consumption through 24, 48, 72 and 96 hours
Measured: Baseline till 168 hours post IP administration
Time to the first postoperative use of rescue opioid analgesics
Time to the first postoperative use of rescue opioid analgesics
Measured: Baseline till 168 hours post IP administration
PK Cmax
Maximum blood concentration (Cmax)
Measured: Baseline till 168 hours post IP administration
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.
Measured: Day 1 through Day 14
PK AUC
Area under the blood concentration-time curve (AUC)
Measured: Baseline till 168 hours post IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 May 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia RepairStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weidong Mi, PhD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551924
- Sponsor's protocol ID
- HR18034-101
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of HR18034 for Pain Management After Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT04551924
- Acronym / sponsor ID
- HR18034-101
- Conditions
- Inguinal Hernia Repair
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I, randomized, double-blind, comparator-controlled study to assess the safety, PK, and efficacy of single postsurgical application of HR18034 compared with Naropin®
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| dose 1 | Experimental | Drug: HR18034HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome |
| dose 2 | Experimental | Drug: HR18034HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome |
| dose 3 | Experimental | Drug: HR18034HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome |
| dose 4 | Experimental | Drug: HR18034HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome |
| Naropin | Active comparator | Drug: NaropinNaronpin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (19 listed)
- Clinically significant abnormal clinical laboratory test value
- Subjects with poor blood pressure control after medication
- Subjects with atrioventricular block or cardiac insufficiency
- Subjects with a history of myocardial infarction or unstable angina pectoris
- Subjects with a history of ischemic stroke or transient ischemic attack
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR18034Also: subjects will receive HR18034.HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome | Drug | dose 1, dose 2, dose 3, dose 4 |
| NaropinAlso: Naropin, 0.5% Injectable SolutionLocal infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg [0.5%, 5mg/mL] x 30mL | Drug | Naropin |
Primary outcome
Number of SAEs and treatment-related severe AEs
Time frame: 14 days
Safety and tolerability:
10 secondary outcomes
Pain intensity assessed using an 11-point NPRS ranging
Time frame: Baseline till 168 hours post IP administration
AUC of NPRS
Time frame: 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
Time frame: 24 hours post IP administration till 168 hours post IP administration
Proportion of pain-free subjects at scheduled timepoints.
Time frame: Baseline till 168 hours post IP administration
Proportion of subjects who used no rescue opioid analgesic
Time frame: Baseline till 168 hours post IP administration
Average daily rescue analgesic consumption
Time frame: Baseline till 168 hours post IP administration
Time to the first postoperative use of rescue opioid analgesics
Time frame: Baseline till 168 hours post IP administration
PK Cmax
Time frame: Baseline till 168 hours post IP administration
Wound assessment by Wound healing and status score
Time frame: Day 1 through Day 14
PK AUC
Time frame: Baseline till 168 hours post IP administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weidong Mi, PhD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HR18034 and Naropin in people with Inguinal Hernia Repair, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weidong Mi, PhD (010-66937116, wwdd1962@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of SAEs and treatment-related severe AEs (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.