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Completed

NCT Number: NCT05318846

A Study to Evaluate the Efficacy and Safety of HRS4800 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.

The study is being conducted to evaluate the efficacy and safety of HRS4800 tablets for postoperative analgesia after impacted teeth removal surgery.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 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 65 years old.
  • Scheduled to remove the impacted tooth.
  • Any NRS score ≥5 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.

Exclusion criteria

  • Subjects who had used other drugs that affect the analgesic effect.
  • Subjects who have infection or other complications on the planned oral surgical site.
  • Subjects with uncontrolled hypertension or hypotension.
  • Subjects with severe cardiovascular and cerebrovascular diseases.
  • Subjects with severe gastrointestinal disease.
  • Subjects with a history of drug or alcohol abuse.
  • Subjects with significant abnormal electrocardiogram.
  • 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.

Treatment and study plan

HRS4800 tablets

Drug

Dosing frequency: single dose; Route of administration: oral

Placebo tablets

Drug

Dosing frequency: single dose; Route of administration: oral

Primary outcomes

  1. 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) 0-8 hours after drug administration

    Time frame: 0-8 hours after drug administration

Secondary outcomes

  1. the Differences of Pain Intensity (PID) form 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

  2. 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) 0-4 hours after drug administration

    Time frame: 0-4 hours after drug administration

  3. 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) 0-12 hours after drug administrationadministration

    Time frame: 0-12 hours after drug administration

  4. 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

  5. Sum of pain relief degree within 4 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR)

    Time frame: 0-4 hours after drug administration

  6. Sum of pain relief degree within 8 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR)

    Time frame: 0-8 hours after drug administration

  7. Sum of pain relief degree within 12 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR)

    Time frame: 0-12 hours after drug administration

  8. Proportion of subjects who reaches 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

  9. Time from drug administration to the first NRS score≤3

    Time frame: 0-12 hours after drug administration

  10. Time from drug administration to the first use of rescue medication

    Time frame: 0-12 hours after drug administration

  11. Proportion of subjects who receive rescue therapy during the treatment period

    Time frame: 0-12 hours after drug administration

  12. 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

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of HRS4800 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 8, 2022
Registry last updated
Apr 8, 2022

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.

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