Postsurgical Pain ManagementPhase 2NCT04699175
A Trial of HR021618 in Postsurgical Pain Management
A Phase 2 study testing HR021618 in people with Postsurgical Pain Management, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy, safety of HR021618 and to explore the reasonable dosage of HR021618 for Pain Management after Orthopaedic surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postsurgical Pain Management
- What is being tested?
- HR021618
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2020to 8 Aug 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 65 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 Orthopaedic surgery
- Male or female
- Meet the weight standard
- Conform to the ASA Physical Status Classification Postoperative randomization criteria Exclusion Criteria
- 1、 Sufficient pain to require IVanalgesia assessed by NRS ranging 2、 No evidence of organ insufficiency, or any other abnormality, during or following surgery
Who cannot join
- History of major surgery
- History of active or high-risk bleeding disorders
- History of myocardial infarction or coronary artery bypass
- History or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study
- Abnormal values in the laboratory
- Have a known allergy 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
Show all 12Show fewer
- 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
- Planned/actual admission to the intensive care unit
- 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, Single-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy of HR021618 for Pain Management Following Orthopaedic Surgery
The study is being conducted to evaluate the efficacy, safety of HR021618 and to explore the reasonable dosage of HR021618 for Pain Management after Orthopaedic surgery.
- Conditions
- Postsurgical Pain Management
- 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; high dose
HR021618Drug
Treatment group B:HR021618; low dose
PlaceboDrug
Treatment group C: HR021618 blank preparation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: HR021618 |
| Treatment group B | Experimental | Not described Receives: Drug: HR021618 |
| Treatment group C | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of Morphine, Post Surgery
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post IP administration.
Measured: 0 hour to 24 hours after IP administration
Secondary outcomes (7)
Usage of Morphine, Post Surgery at other intervals
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-48 hours after IP administration.
Measured: 0 hour to 48 hours after IP administration
Pain intensity assessed using an 11-point NRS ranging
11-point NPRS ranging from a score of 0 to 10.
Measured: Baseline till 48 hours post IP administration
Pain relief assessed using an 5-point likert scale
5-point likert scale from a score of 0 to 4.
Measured: Baseline till 48 hours post IP administration
Time to First Dose of Rescue Analgesia
Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.
Measured: 0 hour to 48 hours after IP administration
Frequency of Doses of Rescue Analgesia Utilized Per Subject
Rescue analgesia was available to subjects with inadequately controlled pain upon request.
Measured: 0 hour to 48 hours after IP administration
Proportion of subjects who received Rescue Analgesia
Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.
Measured: 0 hour to 48 hours after IP administration
Patient Global Assessment (PGA) of Pain Control
PGA of pain control was evaluated by subject reported degree of pain control according to a 5 point scale (0-4)
Measured: 0 hour to 48 hours after IP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start17 Dec 2020
- Primary completion3 Aug 2021
- Study completion8 Aug 2021 (estimated)
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 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
- HR021618 compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 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
- NCT04699175
- Sponsor's protocol ID
- HR021618-202
- Status last verified
- Dec 2020
- First submitted
- 6 Jan 2021
- Last updated
- 6 Aug 2021
- 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 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ, Multicenter, Randomized, Single-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy of HR021618 for Pain Management Following Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT04699175
- Acronym / sponsor ID
- HR021618-202
- Conditions
- Postsurgical Pain Management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 3 Aug 2021 (actual)
- Study completion
- 8 Aug 2021 (estimated)
- First posted
- 7 Jan 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, safety of HR021618 and to explore the reasonable dosage of HR021618 for Pain Management after Orthopaedic surgery.
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
- HR021618 compared with placebo
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: HR021618 |
| Treatment group B | Experimental | Drug: HR021618 |
| Treatment group C | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able and willing to provide a written informed consent
- Subjects requiring elective Orthopaedic surgery
- Male or female
- Meet the weight standard
- Conform to the ASA Physical Status Classification Postoperative randomization criteria Exclusion Criteria
Key exclusion criteria (12 listed)
- History of major surgery
- History of active or high-risk bleeding disorders
- History of myocardial infarction or coronary artery bypass
- History or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study
- Abnormal values in the laboratory
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; high dose | Drug | Treatment group A |
| HR021618Treatment group B:HR021618; low dose | Drug | Treatment group B |
| PlaceboTreatment group C: HR021618 blank preparation. | Drug | Treatment group C |
Primary outcome
Usage of Morphine, Post Surgery
Time frame: 0 hour to 24 hours after IP administration
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post IP administration.
7 secondary outcomes
Usage of Morphine, Post Surgery at other intervals
Time frame: 0 hour to 48 hours after IP administration
Pain intensity assessed using an 11-point NRS ranging
Time frame: Baseline till 48 hours post IP administration
Pain relief assessed using an 5-point likert scale
Time frame: Baseline till 48 hours post IP administration
Time to First Dose of Rescue Analgesia
Time frame: 0 hour to 48 hours after IP administration
Frequency of Doses of Rescue Analgesia Utilized Per Subject
Time frame: 0 hour to 48 hours after IP administration
Proportion of subjects who received Rescue Analgesia
Time frame: 0 hour to 48 hours after IP administration
Patient Global Assessment (PGA) of Pain Control
Time frame: 0 hour to 48 hours after IP administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
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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 Postsurgical Pain Management, 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 6 inclusion and 12 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 6 Aug 2021. 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?
Results are not available in the source record.
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?
Usage of Morphine, Post Surgery (time frame: 0 hour to 24 hours after IP 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 6 Aug 2021.