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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-14

Study Completion Date

2022-03-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Efficacy and Safety of HR18042 Tablets in the Treatment of Postoperative Pain of Impacted Tooth.

NCT04812860

Moderate to Severe Acute Pain

COMPLETED PHASE2

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

NCT05470075

Pain

TERMINATED PHASE2

Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.

NCT05317312

Acute Pain Post Operative Pain Pain

COMPLETED PHASE2

To Evaluate the Safety, Tolerability and Analgesic Efficacy of SAF312 in Postoperative Dental Pain Patients

NCT00986882

Postoperative Pain

COMPLETED PHASE2

Study of Pain Following Removal of Wisdom Teeth With Acute Pulpitis

NCT01153152

Pain

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment group A

Group Type EXPERIMENTAL

HRS4800 tablets

Intervention Type DRUG

Dosing frequency: single dose; Route of administration: oral

Treatment group B

Group Type PLACEBO_COMPARATOR

Placebo tablets

Intervention Type DRUG

Dosing frequency: single dose; Route of administration: oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HRS4800 tablets

Dosing frequency: single dose; Route of administration: oral

Intervention Type DRUG

Placebo tablets

Dosing frequency: single dose; Route of administration: oral

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No