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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318846
• Other study ID #: HRS4800-201
• Status: Completed
• Phase: Phase 2
• Start date: January 14, 2022
• Est. completion date: March 22, 2022

Study information

• Verified date: March 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 22, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Tooth, Impacted

Intervention

Drug:
• HRS4800 tablets
Dosing frequency: single dose; Route of administration: oral
• Placebo tablets
Dosing frequency: single dose; Route of administration: oral

Locations

Country	Name	City	State
China	West China Hospital of Stomatology Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time from drug administration to the first NRS score=3		0-12 hours after drug administration
Secondary	Time from drug administration to the first use of rescue medication		0-12 hours after drug administration
Secondary	Proportion of subjects who receive rescue therapy during the treatment period		0-12 hours after drug administration
Secondary	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