Moderate to Severe Acute PainPhase 2NCT04812860
A Study to Evaluate the Efficacy and Safety of HR18042 Tablets in the Treatment of Postoperative Pain of Impacted Tooth.
A Phase 2 study testing HR18042 and Tramadol hydrochloride ER in people with Moderate to Severe Acute Pain, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study was to evaluate the Efficacy and safety of HR18042 tablets for the Treatment of Post-surgical Pain After extraction of impacted tooth, find the optimal dose. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate to Severe Acute Pain
- What is being tested?
- HR18042 and Tramadol hydrochloride ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2020to 25 Jan 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years old.
- Subjects must have a plan of extraction of impacted tooth.
- Subjects with moderate to severe pain (VAS score ≥ 50mm).This must be measured within a maximum of 4 hours after the end of extraction of impacted tooth.
- weight at least 45kg,and no more than 100kg.
- If a female is of child-bearing potential, she must be using highly effective methods of contraception throughout the study.
- Willingness to comply with the study procedures and requirements.
- willing and able to provide written informed consent for this study.
Who cannot join
- any analgesic medication other than preoperative or intraoperative anaesthetic agents within 12h before taking trial medication medication
- a longacting NSAID within 4 days,or a shortacting NSAID within 1 days prior to dosing.
- any anti-depressive medication, selective serotonin reuptake inhibitors (SSRIs), diet pills et.al. with 30 days of study entry.
- Oral surgical site combined with infection.
- Severe cardiovascular and cerebrovascular diseases.
- Severe gastrointestinal disease.
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- had a history of seizures or drug or alcohol abuse.
- uncontrolled hypertension.
- significant abnormal electrocardiogram
- significant abnormal laboratory value.
- Allergic to the study drug and ingredients.
- Pregnancy, lactation or recent Pregnant plan;
- Subjects who participated in a clinical research study involving an experimental drug before 30 days of study entry.
- other conditions unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital of Stomatology Sichuan University
Chengdu, Sichuan, 610041
About this study
Official title: A Multicenter,Randomized, Double-blind, Dose Ranging , Active- and Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR18042 Tablets for the Treatment of Postoperative Pain of Impacted Tooth.
The purpose of this study was to evaluate the Efficacy and safety of HR18042 tablets for the Treatment of Post-surgical Pain After extraction of impacted tooth, find the optimal dose.
- Conditions
- Moderate to Severe Acute Pain
- Being tested
- HR18042, Tramadol hydrochloride ER, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR18042Drug
Tablet, Dosing frequency: once daily, Route of administration: oral
HR18042Drug
Tablet,Dosing frequency: once daily, Route of administration: oral
HR18042Drug
Tablet,Dosing frequency: once daily, Route of administration: oral
Tramadol hydrochloride ERDrug
Tablet,Dosing frequency: once daily, Route of administration: oral
PlaceboDrug
Tablet,Dosing frequency: once daily, Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| HR18042 100mg | Experimental | Not described Receives: Drug: HR18042 |
| HR18042 125mg | Experimental | Not described Receives: Drug: HR18042 |
| HR18042 200mg | Experimental | Not described Receives: Drug: HR18042 |
| Tramadol hydrochloride ER 100mg | Active comparator | Not described Receives: Drug: Tramadol hydrochloride ER |
| Placebo to match HR18042 and Tramadol hydrochloride ER | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Sum of Pain Intensity Differences（SPID）
SPID is derived as the weighted Sum of Pain Intensity Differences (baseline pain - current pain), measured at different time points via the PI-VAS. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief.
Measured: 0-8hours
Secondary outcomes (14)
the Sum of Pain Intensity Differences（SPID）
Measured: 0-4hours
the Sum of Pain Intensity Differences（SPID）
Measured: 0-12hours
Pain Intensity Differences（PID）
Include pain intensity differences(PIDs) from baseline at each time point. measured at different time points via the PI-VAS.
Measured: 0-12hours
Pain relief（PAR）
pain relief (PAR) on a 5-point Likert scale (0, none, 1, a little, 2, some,3, a lot, 4, complete).
Measured: 0-12hours
the Sum of Pain relief Differences（SPAR）
SPAR is derived as the weighted Sum of Pain relief, measured at different time points via the 5-point Likert scale. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief.
Measured: 0-4hours
the Sum of Pain relief Differences（SPAR）
Measured: 0-8hours
the Sum of Pain relief Differences（SPAR）.
Measured: 0-12hours
Subject who reaches a 30% reduction in pain intensity from baseline
Measured: 4hours、8hours、12hours
Subject who reaches a 50% reduction in pain intensity from baseline
Measured: 4hours、8hours、12hours
time to perceptible pain relief
Measured: 0-12hours
time to meaningful pain relief
Patients used one stopwatch to record the time to 'perceptible' PAR and another stopwatch for the time to'meaningful' PAR.Patients started timing upon intake of study medication and stopped one stopwatch at the onset of perceptible PAR and another upon achieving meaningful PAR.
Measured: 0-12hours
Time to first use of rescue medication
Measured: 0-12hours
Proportion of subjects who take of at least 1 dose of rescue medication
Measured: 0-12hours
Subject's overall assessment of study medication
Patients made an overall assessment of the study medication using a verbal rating scale (excellent, verygood, good, fair, poor).
Measured: 12hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start8 Dec 2020
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Acute PainStudies 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
- A Multicenter,randomized, double-blind, Dose Ranging , controlled with active treatment and placebo, parallel groups, Phase II clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 187 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
- NCT04812860
- Sponsor's protocol ID
- HR18042-201
- Status last verified
- Jun 2025
- First submitted
- 17 Mar 2021
- Last updated
- 22 Jun 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 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter,Randomized, Double-blind, Dose Ranging , Active- and Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR18042 Tablets for the Treatment of Postoperative Pain of Impacted Tooth.
- ClinicalTrials.gov ID
- NCT04812860
- Acronym / sponsor ID
- HR18042-201
- Conditions
- Moderate to Severe Acute Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 24 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 purpose of this study was to evaluate the Efficacy and safety of HR18042 tablets for the Treatment of Post-surgical Pain After extraction of impacted tooth, find the optimal dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- A Multicenter,randomized, double-blind, Dose Ranging , controlled with active treatment and placebo, parallel groups, Phase II clinical trial
| Arm | Type | Receives |
|---|---|---|
| HR18042 100mg | Experimental | Drug: HR18042 |
| HR18042 125mg | Experimental | Drug: HR18042 |
| HR18042 200mg | Experimental | Drug: HR18042 |
| Tramadol hydrochloride ER 100mg | Active comparator | Drug: Tramadol hydrochloride ER |
| Placebo to match HR18042 and Tramadol hydrochloride ER | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 to 75 years old.
- Subjects must have a plan of extraction of impacted tooth.
- Subjects with moderate to severe pain (VAS score ≥ 50mm).This must be measured within a maximum of 4 hours after the end of extraction of impacted tooth.
- weight at least 45kg,and no more than 100kg.
- If a female is of child-bearing potential, she must be using highly effective methods of contraception throughout the study.
Key exclusion criteria (14 listed)
- any analgesic medication other than preoperative or intraoperative anaesthetic agents within 12h before taking trial medication medication
- a longacting NSAID within 4 days,or a shortacting NSAID within 1 days prior to dosing.
- any anti-depressive medication, selective serotonin reuptake inhibitors (SSRIs), diet pills et.al. with 30 days of study entry.
- Oral surgical site combined with infection.
- Severe cardiovascular and cerebrovascular diseases.
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 |
|---|---|---|
| HR18042Tablet, Dosing frequency: once daily, Route of administration: oral | Drug | HR18042 100mg |
| HR18042Tablet,Dosing frequency: once daily, Route of administration: oral | Drug | HR18042 125mg |
| HR18042Tablet,Dosing frequency: once daily, Route of administration: oral | Drug | HR18042 200mg |
| Tramadol hydrochloride ERTablet,Dosing frequency: once daily, Route of administration: oral | Drug | Tramadol hydrochloride ER 100mg |
| PlaceboTablet,Dosing frequency: once daily, Route of administration: oral | Drug | Placebo to match HR18042 and Tramadol hydrochloride ER |
Primary outcome
the Sum of Pain Intensity Differences（SPID）
Time frame: 0-8hours
SPID is derived as the weighted Sum of Pain Intensity Differences (baseline pain - current pain), measured at different time points via the PI-VAS. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief.
14 secondary outcomes
the Sum of Pain Intensity Differences（SPID）
Time frame: 0-4hours
the Sum of Pain Intensity Differences（SPID）
Time frame: 0-12hours
Pain Intensity Differences（PID）
Time frame: 0-12hours
Pain relief（PAR）
Time frame: 0-12hours
the Sum of Pain relief Differences（SPAR）
Time frame: 0-4hours
the Sum of Pain relief Differences（SPAR）
Time frame: 0-8hours
the Sum of Pain relief Differences（SPAR）.
Time frame: 0-12hours
Subject who reaches a 30% reduction in pain intensity from baseline
Time frame: 4hours、8hours、12hours
Subject who reaches a 50% reduction in pain intensity from baseline
Time frame: 4hours、8hours、12hours
time to perceptible pain relief
Time frame: 0-12hours
time to meaningful pain relief
Time frame: 0-12hours
Time to first use of rescue medication
Time frame: 0-12hours
Proportion of subjects who take of at least 1 dose of rescue medication
Time frame: 0-12hours
Subject's overall assessment of study medication
Time frame: 12hours
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 22 Jun 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 HR18042 and Tramadol hydrochloride ER in people with Moderate to Severe Acute Pain, 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 7 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: finished, as of the sponsor's last update on 22 Jun 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?
the Sum of Pain Intensity Differences（SPID） (time frame: 0-8hours). 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 22 Jun 2025.