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

Phase 2

• Conditions: Moderate to Severe Acute Pain
• Interventions: Drug: Tramadol hydrochloride ER; Drug: HR18042; Drug: Placebo

• Registration Number: NCT04812860
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-08
• Primary Completion: 2021-01-25
• Status Verified: 2021-03
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-22
• Last Update Submitted: 2021-03-22
• Study First Posted: 2021-03-24
• Last Update Posted: 2021-03-24
• Study Completion: 2021-04-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

1. 18 to 75 years old.
2. Subjects must have a plan of extraction of impacted tooth.
3. 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.
4. weight at least 45kg,and no more than 100kg.
5. If a female is of child-bearing potential, she must be using highly effective methods of contraception throughout the study.
6. Willingness to comply with the study procedures and requirements.
7. willing and able to provide written informed consent for this study.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tramadol hydrochloride ER 100mg	Tramadol hydrochloride ER	-
HR18042 100mg	HR18042	-
Placebo to match HR18042 and Tramadol hydrochloride ER	Placebo	-
HR18042 125mg	HR18042	-
HR18042 200mg	HR18042	-

Primary Outcome Measures

Name	Time	Method
the Sum of Pain Intensity Differences（SPID）	0-8hours	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.

Secondary Outcome Measures

Name	Time	Method
the Sum of Pain Intensity Differences（SPID）	0-12hours
the Sum of Pain relief Differences（SPAR）	0-8hours
Subject who reaches a 50% reduction in pain intensity from baseline	4hours、8hours、12hours
time to meaningful pain relief	0-12hours	Patients used one stopwatch to record the time to 'perceptible' PAR and another stopwatch for the time to'meaningful' PAR.Patients started timing upon intake of study medication and stopped one stopwatch at the onset of perceptible PAR and another upon achieving meaningful PAR.
Proportion of subjects who take of at least 1 dose of rescue medication	0-12hours
Pain Intensity Differences（PID）	0-12hours	Include pain intensity differences(PIDs) from baseline at each time point. measured at different time points via the PI-VAS.
the Sum of Pain relief Differences（SPAR）.	0-12hours
time to perceptible pain relief	0-12hours
Subject's overall assessment of study medication	12hours	Patients made an overall assessment of the study medication using a verbal rating scale (excellent, verygood, good, fair, poor).
Subject who reaches a 30% reduction in pain intensity from baseline	4hours、8hours、12hours
Time to first use of rescue medication	0-12hours
Pain relief（PAR）	0-12hours	pain relief (PAR) on a 5-point Likert scale (0, none, 1, a little, 2, some,3, a lot, 4, complete).

Trial Locations

Locations (1)

West China Hospital of Stomatology Sichuan University; 🇨🇳 Chengdu, Sichuan, China