Postsurgical Pain ManagementPhase 3NCT05769855
A Study of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
A Phase 3 study testing HR18034, ropivacaine HCl and Sodium Chloride Physiological Solution in people with Postsurgical Pain Management, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postsurgical Pain Management
- What is being tested?
- HR18034, ropivacaine HCl and Sodium Chloride Physiological Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 294 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2023to 30 Oct 2023
- Phase
- Phase 3
- 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
- Subjects requiring hemorrhoidectomy under subarachnoid anesthesia
- 18 kg/m2 ≤ BMI ≤ 30 kg/m2
- Conform to the ASA Physical Status Classification
- Women of childbearing age have a negative pregnancy test and are not nursing
Who cannot join
- Subjects with a history of myocardial infarction or unstable angina pectoris
- Subjects with atrioventricular block or cardiac insufficiency
- Subjects with a history of ischemic stroke or transient ischemic attack
- Subjects with a history of mental illness and a history of cognitive impairment epilepsy
- Subjects with concurrent painful physical condition that may affect postoperative pain assessment
- Spinal or spinal lesions that were determined by the investigator to be unable to tolerate subarachnoid anesthesia
Show all 17Show fewer
- Subjects with a history of hemorrhoidectomy
- Subjects with a history of constipation
- Subjects with a history of perianal disease
- Abnormal values in the laboratory
- Subject with heart rate <50 or >100 beats per minute.
- Subject with refractory hypertension
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study
- History of prohibited drug use
- Participants who may be affected by alcohol, or drug abstinence during the study period;
- 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
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Evaluate the Efficacy and Safety of Local Administration of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.
- Conditions
- Postsurgical Pain Management
- Being tested
- HR18034, ropivacaine HCl, Sodium Chloride Physiological Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR18034Drug
HR18034 380mg
ropivacaine HClDrug
ropivacaine HCl 75mg.
Sodium Chloride Physiological SolutionDrug
Sodium Chloride Physiological Solution 20ml
| Study group | Role | What they receive |
|---|---|---|
| HR18034 | Experimental | Not described Receives: Drug: HR18034 |
| ropivacaine HCl | Active comparator | Not described Receives: Drug: ropivacaine HCl |
| Sodium Chloride Physiological Solution | Placebo comparator | Not described Receives: Drug: Sodium Chloride Physiological Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of Pain Intensity in rest state
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 72 hours.
Measured: 0~72 hours after administration
Secondary outcomes (7)
Proportion of subjects with Pain Rating Scale (NPRS)≥4 during dressing change
Measured: 0~72 hours after administration
Proportion of subjects with Pain Rating Scale (NPRS)≥4 during defecation
Measured: 0~72 hours after administration
AUC of Pain Intensity in rest state
Measured: 0~24 hours after administration
AUC of Pain Intensity in move state
Measured: 0~24 hours，0~72 hours after administration
Proportion of subjects who doesn't recive rescue analgesic
Measured: 0~72 hours after administration
Participant's satisfaction score for analgesia treatment
Measured: 72-hours
Investigator's satisfaction score for analgesia treatment
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 posted15 Mar 2023
- Study start21 Mar 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postsurgical Pain ManagementStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HR18034 compared with active comparator and placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 294 participants (actual)
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
- NCT05769855
- Sponsor's protocol ID
- HR18034-301
- Status last verified
- Feb 2023
- First submitted
- 3 Mar 2023
- Last updated
- 7 Mar 2024
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Evaluate the Efficacy and Safety of Local Administration of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT05769855
- Acronym / sponsor ID
- HR18034-301
- Conditions
- Postsurgical Pain Management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 15 Mar 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.
The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- HR18034 compared with active comparator and placebo
| Arm | Type | Receives |
|---|---|---|
| HR18034 | Experimental | Drug: HR18034 |
| ropivacaine HCl | Active comparator | Drug: ropivacaine HCl |
| Sodium Chloride Physiological Solution | Placebo comparator | Drug: Sodium Chloride Physiological Solution |
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
- Subjects requiring hemorrhoidectomy under subarachnoid anesthesia
- 18 kg/m2 ≤ BMI ≤ 30 kg/m2
- Conform to the ASA Physical Status Classification
- Women of childbearing age have a negative pregnancy test and are not nursing
Key exclusion criteria (17 listed)
- Subjects with a history of myocardial infarction or unstable angina pectoris
- Subjects with atrioventricular block or cardiac insufficiency
- Subjects with a history of ischemic stroke or transient ischemic attack
- Subjects with a history of mental illness and a history of cognitive impairment epilepsy
- Subjects with concurrent painful physical condition that may affect postoperative pain assessment
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 380mg | Drug | HR18034 |
| ropivacaine HClropivacaine HCl 75mg. | Drug | ropivacaine HCl |
| Sodium Chloride Physiological SolutionSodium Chloride Physiological Solution 20ml | Drug | Sodium Chloride Physiological Solution |
Primary outcome
AUC of Pain Intensity in rest state
Time frame: 0~72 hours after administration
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 72 hours.
7 secondary outcomes
Proportion of subjects with Pain Rating Scale (NPRS)≥4 during dressing change
Time frame: 0~72 hours after administration
Proportion of subjects with Pain Rating Scale (NPRS)≥4 during defecation
Time frame: 0~72 hours after administration
AUC of Pain Intensity in rest state
Time frame: 0~24 hours after administration
AUC of Pain Intensity in move state
Time frame: 0~24 hours，0~72 hours after administration
Proportion of subjects who doesn't recive rescue analgesic
Time frame: 0~72 hours after administration
Participant's satisfaction score for analgesia treatment
Time frame: 72-hours
Investigator's satisfaction score for analgesia treatment
Time frame: 72-hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HR18034, ropivacaine HCl and Sodium Chloride Physiological Solution in people with Postsurgical Pain Management, 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 17 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: finished, as of the sponsor's last update on 7 Mar 2024. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC of Pain Intensity in rest state (time frame: 0~72 hours after administration). 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 7 Mar 2024.