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

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

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: HRS4800 tablets; Drug: Placebo tablets

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Stomatology Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 to 65 years old.
2. Scheduled to remove the impacted tooth.
3. Any NRS score ≥5 within 4 hours after the surgery.
4. Willing to comply with the study procedures and requirements.
5. Willing and able to provide written informed consent for this study.

Exclusion Criteria:

1. Subjects who had used other drugs that affect the analgesic effect.
2. Subjects who have infection or other complications on the planned oral surgical site.
3. Subjects with uncontrolled hypertension or hypotension.
4. Subjects with severe cardiovascular and cerebrovascular diseases.
5. Subjects with severe gastrointestinal disease.
6. Subjects with a history of drug or alcohol abuse.
7. Subjects with significant abnormal electrocardiogram.
8. Subjects with significant abnormal laboratory value.
9. Subject who were allergic to the study drug and ingredients.
10. Pregnancy, lactation or having recent pregnant plan.
11. Subjects who participated in other clinical research study 30 days before entering this study.
12. Other conditions unsuitable for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A	Drug: HRS4800 tablets; Dosing frequency: single dose; Route of administration: oral
Placebo Comparator: Treatment group B	Drug: Placebo tablets; Dosing frequency: single dose; Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	0-8 hours after drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
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	0-12 hours after drug administration
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	0-4 hours after drug administration
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	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	0-12 hours after drug administration
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)	0-4 hours after drug administration
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)	0-8 hours after drug administration
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)	0-12 hours after drug administration
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	0-12 hours after drug administration
Time from drug administration to the first NRS score≤3	0-12 hours after drug administration
Time from drug administration to the first use of rescue medication	0-12 hours after drug administration
Proportion of subjects who receive rescue therapy during the treatment period	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)	12 hours after drug administration

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): March 22, 2022

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: HRS4800-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No