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

Primary Purpose

Pain

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

HR18042 tablets

Tramadol hydrochloride SR Tablets

Placebos

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years old.
Scheduled to remove the impacted tooth.
Any NRS score reaches the inclusion criteria 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.

Exclusion Criteria:

Subjects who have used other drugs that have the analgesic effect.
Subjects who have used any drug that affect the efficacy and safety of study drug.
Subjects who have infection or other complications on the planned oral surgical site.
Subjects with hypertension or hypotension during screening period.
Subjects with severe cardiovascular and cerebrovascular diseases.
Subjects with severe gastrointestinal disease.
Subjects with Respiratory diseases.
Subjects with a history of seizure, or drug or alcohol abuse.
Subjects with significant abnormal electrocardiogram result.
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.

Sites / Locations

West China Hospital of Stomatology Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Experimental A: HR18042 175mg

Experimental B: HR18042 225mg

Experimental C: HR18042 275mg

Active Drug Comparator：Tramadol hydrochloride SR Tablets 100mg

Placebo Comparator: Placebos match to HR18042 and Tramadol hydrochloride SR Tablets

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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)

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

Time from drug administration to the first NRS score≤3

Time from drug administration to the first use of rescue medication

Proportion of subjects who receive rescue therapy during the treatment period

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)

Full Information

NCT ID

NCT05470075

First Posted

July 20, 2022

Last Updated

August 29, 2022

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05470075

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 11, 2022 (Actual)

Primary Completion Date

October 31, 2022 (Anticipated)

Study Completion Date

October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental A: HR18042 175mg

Arm Type

Experimental

Arm Title

Experimental B: HR18042 225mg

Arm Type

Experimental

Arm Title

Experimental C: HR18042 275mg

Arm Type

Experimental

Arm Title

Active Drug Comparator：Tramadol hydrochloride SR Tablets 100mg

Arm Type

Active Comparator

Arm Title

Placebo Comparator: Placebos match to HR18042 and Tramadol hydrochloride SR Tablets

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

HR18042 tablets

Intervention Description

Drug: HR 18042 tablets 175mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

HR18042 tablets

Intervention Description

Drug: HR 18042 tablets 225mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

HR18042 tablets

Intervention Description

Drug: HR 18042 tablets 275mg and placebos match to Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

Tramadol hydrochloride SR Tablets

Intervention Description

Drug: Tramadol hydrochloride SR Tablets 100mg and placebos match to HR18042 tablets Dosing frequency: single dose; Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

Drug: Placebos match to HR18042 tablets and Tramadol hydrochloride SR Tablets Dosing frequency: single dose; Route of administration: oral

Primary Outcome Measure Information:

Title

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

Time Frame

0-4 hours after drug administration

Secondary Outcome Measure Information:

Title

Time Frame

0 - 6 hours, 8 hours and 12 hours after drug administration

Title

Time Frame