NCT04812860已完成2 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- the Sum of Pain Intensity Differences（SPID）
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 75 years old.
- •Subjects must have a plan of extraction of impacted tooth.
- •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.
- •weight at least 45kg,and no more than 100kg.
- •If a female is of child-bearing potential, she must be using highly effective methods of contraception throughout the study.
- •Willingness to comply with the study procedures and requirements.
- •willing and able to provide written informed consent for this study.
排除标准
- •any analgesic medication other than preoperative or intraoperative anaesthetic agents within 12h before taking trial medication medication
- •a longacting NSAID within 4 days,or a shortacting NSAID within 1 days prior to dosing.
- •any anti-depressive medication, selective serotonin reuptake inhibitors (SSRIs), diet pills et.al. with 30 days of study entry.
- •Oral surgical site combined with infection.
- •Severe cardiovascular and cerebrovascular diseases.
- •Severe gastrointestinal disease.
- •had a history of seizures or drug or alcohol abuse.
- •uncontrolled hypertension.
- •significant abnormal electrocardiogram
- •significant abnormal laboratory value.
- •Allergic to the study drug and ingredients.
- •Pregnancy, lactation or recent Pregnant plan;
- •Subjects who participated in a clinical research study involving an experimental drug before 30 days of study entry.
- •other conditions unsuitable for participation in the study.
研究组 & 干预措施
HR18042 125mg
Experimental
干预措施: HR18042 (Drug)
HR18042 100mg
Experimental
干预措施: HR18042 (Drug)
HR18042 200mg
Experimental
干预措施: HR18042 (Drug)
Tramadol hydrochloride ER 100mg
Active Comparator
干预措施: Tramadol hydrochloride ER (Drug)
Placebo to match HR18042 and Tramadol hydrochloride ER
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
the Sum of Pain Intensity Differences（SPID）
时间窗: 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.
次要结局
- Subject who reaches a 30% reduction in pain intensity from baseline(4hours、8hours、12hours)
- 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)
- Proportion of subjects who take of at least 1 dose of rescue medication(0-12hours)
- Pain Intensity Differences（PID）(0-12hours)
- the Sum of Pain relief Differences（SPAR）.(0-12hours)
- time to perceptible pain relief(0-12hours)
- Subject's overall assessment of study medication(12hours)
- Time to first use of rescue medication(0-12hours)
- Pain relief（PAR）(0-12hours)
研究者
研究点 (1)
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