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

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Moderate to Severe Acute Pain

Treatments: Drug: HR18042; Drug: Placebo; Drug: Tramadol hydrochloride ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT04812860

HR18042-201

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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187 participants in 5 patient groups, including a placebo group

HR18042 100mg

Experimental group

Treatment:

Drug: HR18042

Drug: HR18042

Drug: HR18042

HR18042 125mg

Experimental group

Treatment:

Drug: HR18042

Drug: HR18042

Drug: HR18042

HR18042 200mg

Experimental group

Treatment:

Drug: HR18042

Drug: HR18042

Drug: HR18042

Tramadol hydrochloride ER 100mg

Active Comparator group

Treatment:

Drug: Tramadol hydrochloride ER

Placebo to match HR18042 and Tramadol hydrochloride ER

Placebo Comparator group

Treatment:

Drug: Placebo