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

• Status: Not yet recruiting
• Trial end date: 2022-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Tramadol

Criteria

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.