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

Primary Purpose

Pain

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HRS4800 tablets
Placebo tablets
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • West China Hospital of Stomatology Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group A

Treatment group B

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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)
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)
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)
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 from drug administration to the first NRS score≤3
Time from drug administration to the first use of rescue medication
Proportion of subjects who receive rescue therapy during the treatment period
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)

Full Information

First Posted
March 4, 2022
Last Updated
April 1, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05318846
Brief Title
A Study to Evaluate the Efficacy and Safety of HRS4800 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
March 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A multicenter, randomized, double-blind, placebo-controlled, phase IIa clinical trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group A
Arm Type
Experimental
Arm Title
Treatment group B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HRS4800 tablets
Intervention Description
Dosing frequency: single dose; Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
Placebo tablets
Intervention Description
Dosing frequency: single dose; Route of administration: oral
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Time from drug administration to the first NRS score≤3
Time Frame
0-12 hours after drug administration
Title
Time from drug administration to the first use of rescue medication
Time Frame
0-12 hours after drug administration
Title
Proportion of subjects who receive rescue therapy during the treatment period
Time Frame
0-12 hours after drug administration
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
West China Hospital of Stomatology Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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