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

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: HRS4800 tablets; Drug: Placebo tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05318846

HRS4800-201

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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38 participants in 2 patient groups, including a placebo group

Treatment group A

Experimental group

Treatment:

Drug: HRS4800 tablets

Treatment group B

Placebo Comparator group

Treatment:

Drug: Placebo tablets