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

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05318846
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.2
• Patients Per Site Per Month: 17.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: HRS4800 tablets; Drug: Placebo tablets	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A multicenter, randomized, double-blind, placebo-controlled, phase IIa clinical trialA multicenter, randomized, double-blind, placebo-controlled, phase IIa clinical trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 14, 2022
• Actual Primary Completion Date: Feb 28, 2022
• Actual Study Completion Date: Mar 22, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 [0-8 hours after drug administration]

Secondary Outcome Measures

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 [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 [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 [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 [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) [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) [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) [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 [0-12 hours after drug administration]

9. Time from drug administration to the first NRS score≤3 [0-12 hours after drug administration]

10. Time from drug administration to the first use of rescue medication [0-12 hours after drug administration]

11. Proportion of subjects who receive rescue therapy during the treatment period [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) [12 hours after drug administration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital of Stomatology Sichuan University	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05318846
• Other Study ID Numbers: HRS4800-201
• First Posted: Apr 8, 2022
• Last Update Posted: Apr 8, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tooth, Impacted

Study Results

No Results Posted as of Apr 8, 2022