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

NCT04812860 | Completed Phase 2

• 1 other identifier: HR18042-201
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to evaluate the Efficacy and safety of HR18042 tablets for the Treatment of Post-surgical Pain After extraction of impacted tooth, find the optimal dose.

Conditions

Moderate to Severe Acute Pain

Outcome Measures

Primary Outcomes (1)

• the Sum of Pain Intensity Differences（SPID）

  SPID is derived as the weighted Sum of Pain Intensity Differences (baseline pain - current pain), measured at different time points via the PI-VAS. Time between two consecutive measurements will be used for weighting. Larger values indicate larger pain relief.

  0-8hours

Secondary Outcomes (14)

• the Sum of Pain Intensity Differences（SPID）

  0-4hours

• the Sum of Pain Intensity Differences（SPID）

  0-12hours

• Pain Intensity Differences（PID）

  0-12hours

• Pain relief（PAR）

  0-12hours

• the Sum of Pain relief Differences（SPAR）

  0-4hours

Study Arms (5)

HR18042 100mg

EXPERIMENTAL

Drug: HR18042

HR18042 125mg

EXPERIMENTAL

Drug: HR18042

HR18042 200mg

EXPERIMENTAL

Drug: HR18042

Tramadol hydrochloride ER 100mg

ACTIVE COMPARATOR

Drug: Tramadol hydrochloride ER

Placebo to match HR18042 and Tramadol hydrochloride ER

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HR18042 DRUG

Tablet, Dosing frequency: once daily, Route of administration: oral

HR18042 100mg

Tramadol hydrochloride ER DRUG

Tablet,Dosing frequency: once daily, Route of administration: oral

Tramadol hydrochloride ER 100mg

Placebo DRUG

Tablet,Dosing frequency: once daily, Route of administration: oral

Placebo to match HR18042 and Tramadol hydrochloride ER

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years old.
• Subjects must have a plan of extraction of impacted tooth.
• Subjects with moderate to severe pain (VAS score ≥ 50mm).This must be measured within a maximum of 4 hours after the end of extraction of impacted tooth.
• weight at least 45kg,and no more than 100kg.
• If a female is of child-bearing potential, she must be using highly effective methods of contraception throughout the study.
• Willingness to comply with the study procedures and requirements.
• willing and able to provide written informed consent for this study.

You may not qualify if:

• any analgesic medication other than preoperative or intraoperative anaesthetic agents within 12h before taking trial medication medication
• a longacting NSAID within 4 days,or a shortacting NSAID within 1 days prior to dosing.
• any anti-depressive medication, selective serotonin reuptake inhibitors (SSRIs), diet pills et.al. with 30 days of study entry.
• Oral surgical site combined with infection.
• Severe cardiovascular and cerebrovascular diseases.
• Severe gastrointestinal disease.
• had a history of seizures or drug or alcohol abuse.
• uncontrolled hypertension.
• significant abnormal electrocardiogram
• significant abnormal laboratory value.
• Allergic to the study drug and ingredients.
• Pregnancy, lactation or recent Pregnant plan;
• Subjects who participated in a clinical research study involving an experimental drug before 30 days of study entry.
• 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

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, Dose Ranging , controlled with active treatment and placebo, parallel groups, Phase II clinical trial

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 24, 2021
• Study Start: December 8, 2020
• Primary Completion: January 25, 2021
• Study Completion: January 25, 2021
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

CN (1)