Postsurgical Pain ManagementPhase 2NCT05376904
A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.
A Phase 2 study testing HR18034 and ropivacaine HCl. in people with Postsurgical Pain Management, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 18 sites in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy. To explore the reasonable dosage 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 and ropivacaine HCl.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 18 sitesChina
- Study dates
- 13 Jun 2022to 5 Oct 2022
- 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
- Subjects requiring hemorrhoidectomy under subarachnoid anesthesia
- 18 kg/m2 ≤ BMI ≤ 28 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
- Subjects with myelopathy or spinal disease
Show all 15Show fewer
- Subjects with a history of hemorrhoidectomy
- Abnormal values in the laboratory
- Subject with a history of substance abuse and drug abuse
- 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 substance abuse, drug use and/or alcohol abuse
- HBsAg, HCVAb, HIV antibody and syphilis antibody tested positive during screening 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
18 sites in 1 country.
18 sites in 1 country
China18 sites
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100005
the first People's Hospital of Changde
Changde, Hunan, 415000
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001
Dongguan people's Hospital
Dongguan, Guangdong, 523000
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Jiaxing Second Hospital
Jiaxing, Zhejiang, 314000
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250000
Nanning Second People's Hospital
Nanning, Guangxi, 530000
Li Huili Hospital of Ningbo Medical Center
Ningbo, Zhejiang, 315040
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110000
Traditional Chinese Medicine Hospital of Hebei Province
Shijiazhuang, Hebei, 050000
Shiyan Taihe Hospital
Shiyan, Hubei, 442099
Taizhou People's Hospital
Taizhou, Jiangsu, 225300
the First Affiliated Hospital of Xi'An Jiaotong University
Xi’an, Shanxi, 710061
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, 710077
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-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. To explore the reasonable dosage of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.
- Conditions
- Postsurgical Pain Management
- Being tested
- HR18034, ropivacaine HCl.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR18034Drug
HR18034 low dose
HR18034Drug
HR18034 midium dose
HR18034Drug
HR18034 high dose
ropivacaine HCl.Drug
ropivacaine HCl.
| Study group | Role | What they receive |
|---|---|---|
| HR18034 dose 1 | Experimental | Not described Receives: Drug: HR18034 |
| HR18034 dose 2 | Experimental | Not described Receives: Drug: HR18034 |
| HR18034 dose 3 | Experimental | Not described Receives: Drug: HR18034 |
| ropivacaine HCl | Active comparator | Not described Receives: Drug: ropivacaine HCl. |
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)
AUC of Pain Intensity in rest state
AUC of Pain Intensity in rest state
Measured: 0~24 hours，0~48 hours after administration
AUC of Pain Intensity in move state
AUC of Pain Intensity in move state
Measured: 0~24 hours，0~48 hours，0~72 hours after administration
Pain intensity in rest state assessed using an 11-point NPRS ranging
11-point NPRS ranging from a score of 0 to 10
Measured: 0~72 hours after administration
Pain intensity in move state assessed using an 11-point NPRS ranging
11-point NPRS ranging from a score of 0 to 10
Measured: 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 posted17 May 2022
- Study start13 Jun 2022
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
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 2
- Primary purpose
- Treatment
- 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
- 86 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
- NCT05376904
- Sponsor's protocol ID
- HR18034-202
- Status last verified
- May 2022
- First submitted
- 11 May 2022
- Last updated
- 20 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 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Local Administration of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
- ClinicalTrials.gov ID
- NCT05376904
- Acronym / sponsor ID
- HR18034-202
- Conditions
- Postsurgical Pain Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 17 May 2022 (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. To explore the reasonable dosage 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
- 4
- Model description
- HR18034 compared with active comparator
| Arm | Type | Receives |
|---|---|---|
| HR18034 dose 1 | Experimental | Drug: HR18034 |
| HR18034 dose 2 | Experimental | Drug: HR18034 |
| HR18034 dose 3 | Experimental | Drug: HR18034 |
| ropivacaine HCl | Active comparator | Drug: ropivacaine HCl. |
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 ≤ 28 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 (15 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 low dose | Drug | HR18034 dose 1 |
| HR18034HR18034 midium dose | Drug | HR18034 dose 2 |
| HR18034HR18034 high dose | Drug | HR18034 dose 3 |
| ropivacaine HCl.ropivacaine HCl. | Drug | ropivacaine HCl |
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
AUC of Pain Intensity in rest state
Time frame: 0~24 hours，0~48 hours after administration
AUC of Pain Intensity in move state
Time frame: 0~24 hours，0~48 hours，0~72 hours after administration
Pain intensity in rest state assessed using an 11-point NPRS ranging
Time frame: 0~72 hours after administration
Pain intensity in move state assessed using an 11-point NPRS ranging
Time frame: 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 20 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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites 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 HCl. in people with Postsurgical Pain Management, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 18 sites 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 15 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 20 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 18 sites 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?
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 20 Mar 2023.