Thoracoscopic LobectomyPhase 2NCT05744674
Phase Ⅱ Study of Intercostal Nerve Block With HR18034 for Postsurgical Pain Management
A Phase 2 study testing HR18034 and Ropivacaine Hydrochloride Injection in people with Thoracoscopic Lobectomy, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection intercostal nerve block with HR18034 for postoperative pain management compared with ropivacaine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoscopic Lobectomy
- What is being tested?
- HR18034 and Ropivacaine Hydrochloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2023to 30 Jun 2023
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent
- Scheduled to undergo thoracoscopic lobectomy under general anesthesia.
- Male or female, aged 18 years and older inclusive
- Body mass index (BMI) 18-30 kg/m2 inclusive
- American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ~Ⅱ
Who cannot join
- Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization;
- Subjects with a history of ischemic stroke or transient ischemic attack (TIA)
- Subjects with a history of mental system diseases and cognitive dysfunction
- Combination of other pain conditions that may affect postoperative pain assessment
- Combination with ventilation disorders caused by airway or spinal anatomical factors, bronchiectasis, and severe chest adhesions on the surgical side
- Clinically significant abnormal clinical laboratory test value
Show all 14Show fewer
- Allergic to a drug ingredient or component
- Use of any of medications, which affect drug metabolism or analgesia evaluation, within 5 half-lives or as specified prior to the study surgical procedure
- History of alcohol abuse or prescription and/or illicit drug abuse
- Subjects with special diets (including tobacco, grapefruit and caffeine)
- Pregnant or nursing women
- No birth control during the specified period of time
- Participated in clinical trials of other drugs (received experimental drugs)
- 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
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Jianxing He
About this study
Official title: A Phase Ⅱ Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Single Injection Intercostal Nerve Block With HR18034 for Postoperative Pain Management
Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection intercostal nerve block with HR18034 for postoperative pain management compared with ropivacaine.
- Conditions
- Thoracoscopic Lobectomy
- Being tested
- HR18034, Ropivacaine Hydrochloride Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR18034Drug
HR18034 228mg/342mg/456mg
Ropivacaine Hydrochloride InjectionDrug
Ropivacaine Hydrochloride Injection 60mg/90mg/120mg
| Study group | Role | What they receive |
|---|---|---|
| HR18034 | Experimental | Not described Receives: Drug: HR18034 |
| Ropivacaine Hydrochloride Injection | Active comparator | Not described Receives: Drug: Ropivacaine Hydrochloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-72 of the NRS-A (or cough) pain intensity scores.
AUC of NRS pain intensity scores at activity (NRS-A) through 72 hours after the beginning of study drug administration.
Measured: 0 to 72 hours
Secondary outcomes (7)
AUC of the NRS-A (or cough) pain intensity scores.
AUC of NRS pain intensity scores at activity (NRS-A) or cough for time periods 0-12, 12-24, 12-48, 12-72 hours.
Measured: 0-12, 12-24,12-48, 12-72 hours
AUC of the NRS-R pain intensity scores.
AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-12, 12-24,12-48, 12-72, 0-72 hours.
Measured: 0-12, 12-24,12-48, 12-72, 0-72 hours
Proportion of subjects who used no rescue opioid analgesic.
Proportion of subjects who used no rescue opioid analgesic through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration.
Measured: 0-24, 24-48, 48-72, 0-72 hours
Total rescue analgesic consumption.
Total rescue analgesic consumption through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration.
Measured: 0-24, 24-48, 48-72, 0-72 hours
Time to the first postoperative use of rescue opioid analgesics.
Time to the first postoperative use of rescue opioid analgesics 0-72 hours after the beginning of study drug administration.
Measured: 0-72 hours
Subjects' satisfaction rating
Subjects' satisfaction rating with postsurgical pain control at 72 hours.
Measured: 72 hours
Investigators' satisfaction rating
Investigators' satisfaction rating with postsurgical pain control at 72 hours.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start21 Feb 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoscopic LobectomyStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HR18034 compared with active comparator
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744674
- Sponsor's protocol ID
- HR18034-203
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Single Injection Intercostal Nerve Block With HR18034 for Postoperative Pain Management
- ClinicalTrials.gov ID
- NCT05744674
- Acronym / sponsor ID
- HR18034-203
- Conditions
- Thoracoscopic Lobectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 27 Feb 2023 (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 Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection intercostal nerve block with HR18034 for postoperative pain management compared with ropivacaine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- HR18034 compared with active comparator
| Arm | Type | Receives |
|---|---|---|
| HR18034 | Experimental | Drug: HR18034 |
| Ropivacaine Hydrochloride Injection | Active comparator | Drug: Ropivacaine Hydrochloride Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able and willing to provide a written informed consent
- Scheduled to undergo thoracoscopic lobectomy under general anesthesia.
- Male or female, aged 18 years and older inclusive
- Body mass index (BMI) 18-30 kg/m2 inclusive
- American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ~Ⅱ
Key exclusion criteria (14 listed)
- Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization;
- Subjects with a history of ischemic stroke or transient ischemic attack (TIA)
- Subjects with a history of mental system diseases and cognitive dysfunction
- Combination of other pain conditions that may affect postoperative pain assessment
- Combination with ventilation disorders caused by airway or spinal anatomical factors, bronchiectasis, and severe chest adhesions on the surgical side
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 |
|---|---|---|
| HR18034HR18034 228mg/342mg/456mg | Drug | HR18034 |
| Ropivacaine Hydrochloride InjectionRopivacaine Hydrochloride Injection 60mg/90mg/120mg | Drug | Ropivacaine Hydrochloride Injection |
Primary outcome
AUC0-72 of the NRS-A (or cough) pain intensity scores.
Time frame: 0 to 72 hours
AUC of NRS pain intensity scores at activity (NRS-A) through 72 hours after the beginning of study drug administration.
7 secondary outcomes
AUC of the NRS-A (or cough) pain intensity scores.
Time frame: 0-12, 12-24,12-48, 12-72 hours
AUC of the NRS-R pain intensity scores.
Time frame: 0-12, 12-24,12-48, 12-72, 0-72 hours
Proportion of subjects who used no rescue opioid analgesic.
Time frame: 0-24, 24-48, 48-72, 0-72 hours
Total rescue analgesic consumption.
Time frame: 0-24, 24-48, 48-72, 0-72 hours
Time to the first postoperative use of rescue opioid analgesics.
Time frame: 0-72 hours
Subjects' satisfaction rating
Time frame: 72 hours
Investigators' satisfaction rating
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HR18034 and Ropivacaine Hydrochloride Injection in people with Thoracoscopic Lobectomy, run by Shanghai Hengrui Pharmaceutical 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 5 inclusion and 14 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 15 Mar 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Qin Liu (+0518-82342973, qin.liu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-72 of the NRS-A (or cough) pain intensity scores. (time frame: 0 to 72 hours). 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 15 Mar 2023.