PainPhase 2NCT05470075
A Study to Evaluate the Efficacy and Safety of HR18042 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.
A Phase 2 study testing HR18042 tablets and Tramadol hydrochloride SR Tablets in people with Pain, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial, and the purpose of the study is to evaluate the efficacy and safety of HR18042 tablets for postoperative analgesia after impacted teeth removal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- HR18042 tablets and Tramadol hydrochloride SR Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2022to 16 Dec 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
- Age ≥ 18 years old.
- Scheduled to remove the impacted tooth.
- Any NRS score reaches the inclusion criteria within 4 hours after the surgery.
- Willing to comply with the study procedures and requirements.
- Willing and able to provide written informed consent for this study.
Who cannot join
- Subjects who have used other drugs that have the analgesic effect.
- Subjects who have used any drug that affect the efficacy and safety of study drug.
- Subjects who have infection or other complications on the planned oral surgical site.
- Subjects with hypertension or hypotension during screening period.
- Subjects with severe cardiovascular and cerebrovascular diseases.
- Subjects with severe gastrointestinal disease.
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- Subjects with Respiratory diseases.
- Subjects with a history of seizure, or drug or alcohol abuse.
- Subjects with significant abnormal electrocardiogram result.
- Subjects with significant abnormal laboratory value.
- Subject who were allergic to the study drug and ingredients.
- Pregnancy, lactation or having recent pregnant plan.
- Subjects who participated in other clinical research study 30 days before entering this study.
- 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 Finding, Parallel Controlled With Active Drug and Placebo, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR18042 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery
This is a multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial, and the purpose of the study is to evaluate the efficacy and safety of HR18042 tablets for postoperative analgesia after impacted teeth removal surgery.
- Conditions
- Pain
- Being tested
- HR18042 tablets, Tramadol hydrochloride SR Tablets, Placebos
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR18042 tabletsDrug
Drug: HR 18042 tablets 175mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral
HR18042 tabletsDrug
Drug: HR 18042 tablets 225mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral
HR18042 tabletsDrug
Drug: HR 18042 tablets 275mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral
Tramadol hydrochloride SR TabletsDrug
Drug: Tramadol hydrochloride SR Tablets 100mg and placebos match to HR18042 tablets Dosing frequency: single dose; Route of administration: oral
PlacebosDrug
Drug: Placebos match to HR18042 tablets and Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Experimental A: HR18042 175mg | Experimental | Not described Receives: Drug: HR18042 tablets |
| Experimental B: HR18042 225mg | Experimental | Not described Receives: Drug: HR18042 tablets |
| Experimental C: HR18042 275mg | Experimental | Not described Receives: Drug: HR18042 tablets |
| Active Drug Comparator：Tramadol hydrochloride SR Tablets 100mg | Active comparator | Not described Receives: Drug: Tramadol hydrochloride SR Tablets |
| Placebo Comparator: Placebos match to HR18042 and Tramadol hydrochloride SR Tablets | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) within 4 hours after drug administration
Measured: 0-4 hours after drug administration
Secondary outcomes (9)
the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) within 6 hours, 8 hours and 12 hours after drug administration
Measured: 0 - 6 hours, 8 hours and 12 hours after drug administration
the Differences of Pain Intensity (PID) from each evaluating timepoint to baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) after drug administration
Measured: 0-12 hours after drug administration
Pain relief degree at each evaluating timepoint using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration
Measured: 0-12 hours after drug administration
Sum of pain relief degree using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) within 4 hours, 6 hours, 8 hours, 12 hours after drug administration (SPAR)
Measured: 0 - 4 hours, 6 hours, 8 hours and 12 hours after drug administration
Proportion of subjects who reach a 50% reduction in pain intensity from baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) at each evaluating timepoint
Measured: 0-12 hours after drug administration
Time from drug administration to the first NRS score≤3
Measured: 0-12 hours after drug administration
Time from drug administration to the first use of rescue medication
Measured: 0-12 hours after drug administration
Proportion of subjects who receive rescue therapy during the treatment period
Measured: 0-12 hours after drug administration]
Subject's overall satisfaction score of the study medication using subject satisfaction scale (ranging from 0-10, the larger the number, the higher the satisfaction)
Measured: 12 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start11 Aug 2022
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Why it stopped: The sponsor's R\&D strategy is adjusted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 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
- NCT05470075
- Sponsor's protocol ID
- HR18042-202
- Status last verified
- Jun 2025
- First submitted
- 20 Jul 2022
- Last updated
- 26 Jun 2025
- 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Dose Finding, Parallel Controlled With Active Drug and Placebo, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR18042 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery
- ClinicalTrials.gov ID
- NCT05470075
- Acronym / sponsor ID
- HR18042-202
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The sponsor's R\&D strategy is adjusted.
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 22 Jul 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.
This is a multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial, and the purpose of the study is to evaluate the efficacy and safety of HR18042 tablets for postoperative analgesia after impacted teeth removal surgery.
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
- Multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental A: HR18042 175mg | Experimental | Drug: HR18042 tablets |
| Experimental B: HR18042 225mg | Experimental | Drug: HR18042 tablets |
| Experimental C: HR18042 275mg | Experimental | Drug: HR18042 tablets |
| Active Drug Comparator：Tramadol hydrochloride SR Tablets 100mg | Active comparator | Drug: Tramadol hydrochloride SR Tablets |
| Placebo Comparator: Placebos match to HR18042 and Tramadol hydrochloride SR Tablets | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old.
- Scheduled to remove the impacted tooth.
- Any NRS score reaches the inclusion criteria within 4 hours after the surgery.
- Willing to comply with the study procedures and requirements.
- Willing and able to provide written informed consent for this study.
Key exclusion criteria (14 listed)
- Subjects who have used other drugs that have the analgesic effect.
- Subjects who have used any drug that affect the efficacy and safety of study drug.
- Subjects who have infection or other complications on the planned oral surgical site.
- Subjects with hypertension or hypotension during screening period.
- Subjects with 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 |
|---|---|---|
| HR18042 tabletsDrug: HR 18042 tablets 175mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral | Drug | Experimental A: HR18042 175mg |
| HR18042 tabletsDrug: HR 18042 tablets 225mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral | Drug | Experimental B: HR18042 225mg |
| HR18042 tabletsDrug: HR 18042 tablets 275mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral | Drug | Experimental C: HR18042 275mg |
| Tramadol hydrochloride SR TabletsDrug: Tramadol hydrochloride SR Tablets 100mg and placebos match to HR18042 tablets Dosing frequency: single dose; Route of administration: oral | Drug | Active Drug Comparator：Tramadol hydrochloride SR Tablets 100mg |
| PlacebosDrug: Placebos match to HR18042 tablets and Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral | Drug | Placebo Comparator: Placebos match to HR18042 and Tramadol hydrochloride SR Tablets |
Primary outcome
the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) within 4 hours after drug administration
Time frame: 0-4 hours after drug administration
9 secondary outcomes
the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) within 6 hours, 8 hours and 12 hours after drug administration
Time frame: 0 - 6 hours, 8 hours and 12 hours after drug administration
the Differences of Pain Intensity (PID) from each evaluating timepoint to baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) after drug administration
Time frame: 0-12 hours after drug administration
Pain relief degree at each evaluating timepoint using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration
Time frame: 0-12 hours after drug administration
Sum of pain relief degree using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) within 4 hours, 6 hours, 8 hours, 12 hours after drug administration (SPAR)
Time frame: 0 - 4 hours, 6 hours, 8 hours and 12 hours after drug administration
Proportion of subjects who reach a 50% reduction in pain intensity from baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) at each evaluating timepoint
Time frame: 0-12 hours after drug administration
Time from drug administration to the first NRS score≤3
Time frame: 0-12 hours after drug administration
Time from drug administration to the first use of rescue medication
Time frame: 0-12 hours after drug administration
Proportion of subjects who receive rescue therapy during the treatment period
Time frame: 0-12 hours after drug administration]
Subject's overall satisfaction score of the study medication using subject satisfaction scale (ranging from 0-10, the larger the number, the higher the satisfaction)
Time frame: 12 hours after drug administration
Results and safety
The study was stopped early (reason given: The sponsor's R\&D strategy is adjusted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- 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 2 study testing HR18042 tablets and Tramadol hydrochloride SR Tablets in people with 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 5 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: stopped early, as of the sponsor's last update on 26 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 was stopped early (reason given: The sponsor's R\&D strategy is adjusted.). 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?
the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) within 4 hours after drug administration (time frame: 0-4 hours after drug 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 26 Jun 2025.