NCT05318846已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of HRS4800 Tablets for Postoperative Analgesia After Impacted Teeth Removal Surgery
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
- 38
- 试验地点
- 1
- 主要终点
- the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) 0-8 hours after drug administration
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of HRS4800 tablets for postoperative analgesia after impacted teeth removal surgery.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years old.
- •Scheduled to remove the impacted tooth.
- •Any NRS score ≥5 within 4 hours after the surgery.
- •Willing to comply with the study procedures and requirements.
- •Willing and able to provide written informed consent for this study.
排除标准
- •Subjects who had used other drugs that affect the analgesic effect.
- •Subjects who have infection or other complications on the planned oral surgical site.
- •Subjects with uncontrolled hypertension or hypotension.
- •Subjects with severe cardiovascular and cerebrovascular diseases.
- •Subjects with severe gastrointestinal disease.
- •Subjects with a history of drug or alcohol abuse.
- •Subjects with significant abnormal electrocardiogram.
- •Subjects with significant abnormal laboratory value.
- •Subject who were allergic to the study drug and ingredients.
- •Pregnancy, lactation or having recent pregnant plan.
- •Subjects who participated in other clinical research study 30 days before entering this study.
- •Other conditions unsuitable for participation in the study.
研究组 & 干预措施
Treatment group A
Experimental
干预措施: HRS4800 tablets (Drug)
Treatment group B
Placebo Comparator
干预措施: Placebo tablets (Drug)
结局指标
主要结局
the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) 0-8 hours after drug administration
时间窗: 0-8 hours after drug administration
次要结局
- the Differences of Pain Intensity (PID) form each evaluating timepoint to baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) after drug administration(0-12 hours after drug administration)
- the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) 0-4 hours after drug administration(0-4 hours after drug administration)
- the Sum of Pain Intensity Differences (SPID) using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) 0-12 hours after drug administrationadministration(0-12 hours after drug administration)
- Pain relief degree at each evaluating timepoint using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration(0-12 hours after drug administration)
- Sum of pain relief degree within 4 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR)(0-4 hours after drug administration)
- Sum of pain relief degree within 8 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR)(0-8 hours after drug administration)
- Sum of pain relief degree within 12 hours using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) after drug administration (SPAR)(0-12 hours after drug administration)
- Proportion of subjects who reaches a 50% reduction in pain intensity from baseline using numerical rating scale (NRS, ranging from 0-10, the larger the number, the more severe the pain) at each evaluating timepoint(0-12 hours after drug administration)
- Time from drug administration to the first NRS score≤3(0-12 hours after drug administration)
- Time from drug administration to the first use of rescue medication(0-12 hours after drug administration)
- Proportion of subjects who receive rescue therapy during the treatment period(0-12 hours after drug administration)
- Subject's overall satisfaction score of the study medication using subject satisfaction scale (ranging from 0-10, the larger the number, the higher the satisfaction)(12 hours after drug administration)
研究者
研究点 (1)
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