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Completed

NCT Number: NCT04812860

A Study to Evaluate the Efficacy and Safety of HR18042 Tablets in 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital of Stomatology Sichuan University

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

HR18042

Drug

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

Tramadol hydrochloride ER

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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.

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)

    Time frame: 0-12hours

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

  4. Pain relief(PAR)

    Time frame: 0-12hours

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

  5. the Sum of Pain relief Differences(SPAR)

    Time frame: 0-4hours

    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.

  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

    Time frame: 0-12hours

    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.

  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

    Time frame: 12hours

    Patients made an overall assessment of the study medication using a verbal rating scale (excellent, verygood, good, fair, poor).

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2021
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.