A Study to Evaluate the Efficacy and Safety of HR18042 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery.

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Pain

Treatments: Drug: Tramadol hydrochloride SR Tablets; Drug: HR18042 tablets; Drug: Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT05470075

HR18042-202

Details and patient eligibility

About

This is a multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial, and the purpose of the study is to evaluate the efficacy and safety of HR18042 tablets for postoperative analgesia after impacted teeth removal surgery.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old.
2. Scheduled to remove the impacted tooth.
3. Any NRS score reaches the inclusion criteria 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 have used other drugs that have the analgesic effect.
2. Subjects who have used any drug that affect the efficacy and safety of study drug.
3. Subjects who have infection or other complications on the planned oral surgical site.
4. Subjects with hypertension or hypotension during screening period.
5. Subjects with severe cardiovascular and cerebrovascular diseases.
6. Subjects with severe gastrointestinal disease.
7. Subjects with Respiratory diseases.
8. Subjects with a history of seizure, or drug or alcohol abuse.
9. Subjects with significant abnormal electrocardiogram result.
10. Subjects with significant abnormal laboratory value.
11. Subject who were allergic to the study drug and ingredients.
12. Pregnancy, lactation or having recent pregnant plan.
13. Subjects who participated in other clinical research study 30 days before entering this study.
14. 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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180 participants in 5 patient groups, including a placebo group

Experimental A: HR18042 175mg

Experimental group

Treatment:

Drug: HR18042 tablets

Experimental B: HR18042 225mg

Experimental group

Treatment:

Drug: HR18042 tablets

Experimental C: HR18042 275mg

Experimental group

Treatment:

Drug: HR18042 tablets

Active Drug Comparator：Tramadol hydrochloride SR Tablets 100mg

Active Comparator group

Treatment:

Drug: Tramadol hydrochloride SR Tablets

Placebo Comparator: Placebos match to HR18042 and Tramadol hydrochloride SR Tablets

Placebo Comparator group

Treatment:

Drug: Placebos