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CompletedNCT04812860Updated Jun 22, 2025

A Study to Evaluate the Efficacy and Safety of HR18042 Tablets in the Treatment of Postoperative Pain of Impacted Tooth.

A Phase 2 interventional study of HR18042 and HR18042 in Moderate to Severe Acute Pain, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-22.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
187
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Moderate to Severe Acute Pain
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 18 to 75 years old.
  2. Subjects must have a plan of extraction of impacted tooth.
  3. 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.
  4. weight at least 45kg,and no more than 100kg.
  5. If a female is of child-bearing potential, she must be using highly effective methods of contraception throughout the study.
  6. Willingness to comply with the study procedures and requirements.
  7. willing and able to provide written informed consent for this study.

Exclusion criteria

Exclusion Criteria:

  1. any analgesic medication other than preoperative or intraoperative anaesthetic agents within 12h before taking trial medication medication
  2. a longacting NSAID within 4 days,or a shortacting NSAID within 1 days prior to dosing.
  3. any anti-depressive medication, selective serotonin reuptake inhibitors (SSRIs), diet pills et.al. with 30 days of study entry.
  4. Oral surgical site combined with infection.
  5. Severe cardiovascular and cerebrovascular diseases.
  6. Severe gastrointestinal disease.
  7. had a history of seizures or drug or alcohol abuse.
  8. uncontrolled hypertension.
  9. significant abnormal electrocardiogram
  10. significant abnormal laboratory value.
  11. Allergic to the study drug and ingredients.
  12. Pregnancy, lactation or recent Pregnant plan;
  13. Subjects who participated in a clinical research study involving an experimental drug before 30 days of study entry.
  14. other conditions unsuitable for participation in the study.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
187 participants (actual)

Study arms

  • Experimental
    HR18042 100mg

    Drug: HR18042

  • Experimental
    HR18042 125mg

    Drug: HR18042

  • Experimental
    HR18042 200mg

    Drug: HR18042

  • Active comparator
    Tramadol hydrochloride ER 100mg

    Drug: Tramadol hydrochloride ER

  • Placebo comparator
    Placebo to match HR18042 and Tramadol hydrochloride ER

    Drug: Placebo

Interventions

  • DrugHR18042

    Tablet, Dosing frequency: once daily, Route of administration: oral

  • DrugHR18042

    Tablet,Dosing frequency: once daily, Route of administration: oral

  • DrugHR18042

    Tablet,Dosing frequency: once daily, Route of administration: oral

  • DrugTramadol hydrochloride ER

    Tablet,Dosing frequency: once daily, Route of administration: oral

  • DrugPlacebo

    Tablet,Dosing frequency: once daily, Route of administration: oral

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0-8hours

Secondary outcomes

  1. the Sum of Pain Intensity Differences（SPID）

    Time frame: 0-4hours

  2. the Sum of Pain Intensity Differences（SPID）

    Time frame: 0-12hours

  3. Pain Intensity Differences（PID）

    Include pain intensity differences(PIDs) from baseline at each time point. measured at different time points via the PI-VAS.

    Time frame: 0-12hours

  4. Pain relief（PAR）

    pain relief (PAR) on a 5-point Likert scale (0, none, 1, a little, 2, some,3, a lot, 4, complete).

    Time frame: 0-12hours

  5. 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.

    Time frame: 0-4hours

  6. the Sum of Pain relief Differences（SPAR）

    Time frame: 0-8hours

  7. the Sum of Pain relief Differences（SPAR）.

    Time frame: 0-12hours

  8. Subject who reaches a 30% reduction in pain intensity from baseline

    Time frame: 4hours、8hours、12hours

  9. Subject who reaches a 50% reduction in pain intensity from baseline

    Time frame: 4hours、8hours、12hours

  10. time to perceptible pain relief

    Time frame: 0-12hours

  11. 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.

    Time frame: 0-12hours

  12. Time to first use of rescue medication

    Time frame: 0-12hours

  13. Proportion of subjects who take of at least 1 dose of rescue medication

    Time frame: 0-12hours

  14. 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).

    Time frame: 12hours

06

Study locations

1 site
  • West China Hospital of Stomatology Sichuan University
    Chengdu, Sichuan 610041, China
07

Registry details

Key details

Study ID
NCT04812860
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Mar 24, 2021
Start date
Dec 8, 2020
Primary completion
Jan 25, 2021
Completion
Jan 25, 2021
Last update
Jun 22, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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