Clinical trial NCT04812860: A Study to Evaluate the Efficacy and Safety of HR18042 Tablets in the Treatment of Postoperative Pain of Impacted Tooth.
Official title: A Multicenter,Randomized, Double-blind, Dose Ranging , Active- and Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR18042 Tablets for the Treatment of Postoperative Pain of Impacted Tooth.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Moderate to Severe Acute Pain
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Multicenter,randomized, double-blind, Dose Ranging , controlled with active treatment and placebo, parallel groups, Phase II clinical trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: the Sum of Pain Intensity Differences（SPID）
timeFrame: 0-8hours
Secondary outcomes:
measure: the Sum of Pain Intensity Differences（SPID）
timeFrame: 0-4hours
measure: the Sum of Pain Intensity Differences（SPID）
timeFrame: 0-12hours
measure: Pain Intensity Differences（PID）
timeFrame: 0-12hours
measure: Pain relief（PAR）
timeFrame: 0-12hours
measure: the Sum of Pain relief Differences（SPAR）
timeFrame: 0-4hours
measure: the Sum of Pain relief Differences（SPAR）
timeFrame: 0-8hours
measure: the Sum of Pain relief Differences（SPAR）.
timeFrame: 0-12hours
measure: Subject who reaches a 30% reduction in pain intensity from baseline
timeFrame: 4hours、8hours、12hours
measure: Subject who reaches a 50% reduction in pain intensity from baseline
timeFrame: 4hours、8hours、12hours
measure: time to perceptible pain relief
timeFrame: 0-12hours
measure: time to meaningful pain relief
timeFrame: 0-12hours
measure: Time to first use of rescue medication
timeFrame: 0-12hours
measure: Proportion of subjects who take of at least 1 dose of rescue medication
timeFrame: 0-12hours
measure: Subject's overall assessment of study medication
timeFrame: 12hours
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Stomatology Sichuan University
state: Sichuan
Study officials:
References: