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

Pain Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Dose Finding, Parallel Controlled With Active Drug and Placebo, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR18042 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05470075
• Other study ID #: HR18042-202
• Status: Recruiting
• Phase: Phase 2
• Start date: August 11, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: July 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Qin Liu
• Phone: +0518-82342973
• Email: qin.liu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Tooth, Impacted

Intervention

Drug:
• HR18042 tablets
Drug: HR 18042 tablets 175mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral
• HR18042 tablets
Drug: HR 18042 tablets 225mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral
• HR18042 tablets
Drug: HR 18042 tablets 275mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral
• Tramadol hydrochloride SR Tablets
Drug: Tramadol hydrochloride SR Tablets 100mg and placebos match to HR18042 tablets Dosing frequency: single dose; Route of administration: oral
• Placebos
Drug: Placebos match to HR18042 tablets and Tramadol hydrochloride SR 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) within 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) within 6 hours, 8 hours and 12 hours after drug administration		0 - 6 hours, 8 hours and 12 hours after drug administration
Secondary	the Differences of Pain Intensity (PID) from 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	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 using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) within 4 hours, 6 hours, 8 hours, 12 hours after drug administration (SPAR)		0 - 4 hours, 6 hours, 8 hours and 12 hours after drug administration
Secondary	Proportion of subjects who reach 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