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

NCT05318846 | Completed Phase 2

• 1 other identifier: HRS4800-201
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (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 Outcomes (12)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: HRS4800 tablets

Treatment group B

PLACEBO COMPARATOR

Drug: Placebo tablets

Interventions

HRS4800 tablets DRUG

Dosing frequency: single dose; Route of administration: oral

Treatment group A

Placebo tablets DRUG

Dosing frequency: single dose; Route of administration: oral

Treatment group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years old.
• Scheduled to remove the impacted tooth.
• Any NRS score ≥5 within 4 hours after the surgery.
• Willing to comply with the study procedures and requirements.
• Willing and able to provide written informed consent for this study.

You may not qualify if:

• Subjects who had used other drugs that affect the analgesic effect.
• Subjects who have infection or other complications on the planned oral surgical site.
• Subjects with uncontrolled hypertension or hypotension.
• Subjects with severe cardiovascular and cerebrovascular diseases.
• Subjects with severe gastrointestinal disease.
• Subjects with a history of drug or alcohol abuse.
• Subjects with significant abnormal electrocardiogram.
• Subjects with significant abnormal laboratory value.
• Subject who were allergic to the study drug and ingredients.
• Pregnancy, lactation or having recent pregnant plan.
• Subjects who participated in other clinical research study 30 days before entering this study.
• Other conditions unsuitable for participation in the study.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

West China Hospital of Stomatology Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multicenter, randomized, double-blind, placebo-controlled, phase IIa clinical trial

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: April 8, 2022
• Study Start: January 14, 2022
• Primary Completion: February 28, 2022
• Study Completion: March 22, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-03

Locations

CN (1)