A Study to Evaluate the Efficacy and Safety of HR18042 Tablets in the Treatment of Postoperative Pain of Impacted Tooth.
NCT ID: NCT04812860
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
187 participants
INTERVENTIONAL
2020-12-08
2021-01-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HR18042 100mg
HR18042
Tablet, Dosing frequency: once daily, Route of administration: oral
HR18042 125mg
HR18042
Tablet,Dosing frequency: once daily, Route of administration: oral
HR18042 200mg
HR18042
Tablet,Dosing frequency: once daily, Route of administration: oral
Tramadol hydrochloride ER 100mg
Tramadol hydrochloride ER
Tablet,Dosing frequency: once daily, Route of administration: oral
Placebo to match HR18042 and Tramadol hydrochloride ER
Placebo
Tablet,Dosing frequency: once daily, Route of administration: oral
Interventions
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HR18042
Tablet, Dosing frequency: once daily, Route of administration: oral
HR18042
Tablet,Dosing frequency: once daily, Route of administration: oral
HR18042
Tablet,Dosing frequency: once daily, Route of administration: oral
Tramadol hydrochloride ER
Tablet,Dosing frequency: once daily, Route of administration: oral
Placebo
Tablet,Dosing frequency: once daily, Route of administration: oral
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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West China Hospital of Stomatology Sichuan University
Chengdu, Sichuan, China
Countries
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Other Identifiers
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HR18042-201
Identifier Type: -
Identifier Source: org_study_id
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