Pain After Abdominal SurgeryPhase 2NCT04811053
HR021618 in Moderate to Severe Pain After Abdominal Surgery
A Phase 2 study testing HR021618 in people with Pain After Abdominal Surgery, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of HR021618 in the treatment of moderate to severe pain after abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain After Abdominal Surgery
- What is being tested?
- HR021618
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2021to 15 Jul 2021
- 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 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
- Subjects requiring elective general anesthesia abdominal surgery
- Male or female
- Meet BMI standard
- Conform to the ASA Physical Status Classification
Who cannot join
- Subjects with a history of abdominal surgery
- Subjects had hemorrhagic disorders
- Subjects had cardiac, serious hepatic or renal, cardiovascular or cerebrovascular, metabolic, psychiatric disorders, chronic pain, or malignant tumors
- Subjects with poor blood pressure control after medication
- Abnormal QTc
- Abnormal random blood glucose
Show all 13Show fewer
- Abnormal values in the laboratory
- Allergic to meloxicam or any excipient of HR021618, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study
- Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives
- 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.
About this study
Official title: A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of HR021618 in the Treatment of Moderate to Severe Pain After Abdominal Surgery
The study is being conducted to evaluate the efficacy and safety of HR021618 in the treatment of moderate to severe pain after abdominal surgery.
- Conditions
- Pain After Abdominal Surgery
- Being tested
- HR021618, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR021618Drug
Treatment group A: HR021618 injection
PlaceboDrug
Treatment group B: Saline injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: HR021618 |
| Treatment group B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC48
Area under the pain intensity-time curve.
Measured: 48 hours after recovery from anesthesia] Area under the pain intensity-time curve.
Secondary outcomes (7)
Total consumption of morphine over 0-48, 0-24, 24-48 hours
Total consumption of morphine after recovery from anesthesia.
Measured: 48 hours after recovery from anesthesia
AUC3, AUC24, AUC15-21, AUC18-24, AUC24-28, AUC39-45, AUC42-48
Area under the pain intensity-time curve.
Measured: 48 hours after recovery from anesthesia
Time of the first dose of rescue analgesia
Time of the first dose of rescue analgesia after recovery from anesthesia.
Measured: 48 hours after recovery from anesthesia
Proportion of subjects receiving rescue analgesia
Proportion of subjects receiving rescue analgesia after recovery from anesthesia.
Measured: 48 hours after recovery from anesthesia
Frequency of doses of rescue analgesia
Frequency of doses of rescue analgesia after recovery from anesthesia.
Measured: 48 hours after recovery from anesthesia
Subjects' satisfaction rating
Subjects' satisfaction rating.
Measured: 48 hours after recovery from anesthesia
Anesthesiologist satisfaction rating
Anesthesiologist satisfaction rating.
Measured: 48 hours after recovery from anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start12 Apr 2021
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After Abdominal SurgeryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811053
- Sponsor's protocol ID
- HR021618-203
- Status last verified
- May 2025
- First submitted
- 19 Mar 2021
- Last updated
- 15 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of HR021618 in the Treatment of Moderate to Severe Pain After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04811053
- Acronym / sponsor ID
- HR021618-203
- Conditions
- Pain After Abdominal Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 23 Mar 2021 (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 HR021618 in the treatment of moderate to severe pain after abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HR021618 |
| Treatment group B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- 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 elective general anesthesia abdominal surgery
- Male or female
- Meet BMI standard
- Conform to the ASA Physical Status Classification
Key exclusion criteria (13 listed)
- Subjects with a history of abdominal surgery
- Subjects had hemorrhagic disorders
- Subjects had cardiac, serious hepatic or renal, cardiovascular or cerebrovascular, metabolic, psychiatric disorders, chronic pain, or malignant tumors
- Subjects with poor blood pressure control after medication
- Abnormal QTc
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 |
|---|---|---|
| HR021618Treatment group A: HR021618 injection | Drug | Treatment group A |
| PlaceboTreatment group B: Saline injection | Drug | Treatment group B |
Primary outcome
AUC48
Time frame: 48 hours after recovery from anesthesia] Area under the pain intensity-time curve.
Area under the pain intensity-time curve.
7 secondary outcomes
Total consumption of morphine over 0-48, 0-24, 24-48 hours
Time frame: 48 hours after recovery from anesthesia
AUC3, AUC24, AUC15-21, AUC18-24, AUC24-28, AUC39-45, AUC42-48
Time frame: 48 hours after recovery from anesthesia
Time of the first dose of rescue analgesia
Time frame: 48 hours after recovery from anesthesia
Proportion of subjects receiving rescue analgesia
Time frame: 48 hours after recovery from anesthesia
Frequency of doses of rescue analgesia
Time frame: 48 hours after recovery from anesthesia
Subjects' satisfaction rating
Time frame: 48 hours after recovery from anesthesia
Anesthesiologist satisfaction rating
Time frame: 48 hours after recovery from anesthesia
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 15 May 2025.
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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 2 study testing HR021618 in people with Pain After Abdominal Surgery, 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 5 inclusion and 13 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 15 May 2025. 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 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?
AUC48 (time frame: 48 hours after recovery from anesthesia] Area under the pain intensity-time curve.). 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 May 2025.