NCT05470075终止2 期
A Multicenter, Randomized, Double-blind, Dose Finding, Parallel Controlled With Active Drug and Placebo, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR18042 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
- 终止
- 入组人数
- 110
- 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) within 4 hours after drug administration
研究概览
简要总结
This is a multicenter, randomized, double-blind, dose finding, parallel controlled with active drug and placebo, phase II clinical trial, and the purpose of the study is to evaluate the efficacy and safety of HR18042 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Scheduled to remove the impacted tooth.
- •Any NRS score reaches the inclusion criteria 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 have used other drugs that have the analgesic effect.
- •Subjects who have used any drug that affect the efficacy and safety of study drug.
- •Subjects who have infection or other complications on the planned oral surgical site.
- •Subjects with hypertension or hypotension during screening period.
- •Subjects with severe cardiovascular and cerebrovascular diseases.
- •Subjects with severe gastrointestinal disease.
- •Subjects with Respiratory diseases.
- •Subjects with a history of seizure, or drug or alcohol abuse.
- •Subjects with significant abnormal electrocardiogram result.
- •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
Experimental A: HR18042 175mg
Experimental
干预措施: HR18042 tablets (Drug)
Experimental B: HR18042 225mg
Experimental
干预措施: HR18042 tablets (Drug)
Experimental C: HR18042 275mg
Experimental
干预措施: HR18042 tablets (Drug)
Active Drug Comparator：Tramadol hydrochloride SR Tablets 100mg
Active Comparator
干预措施: Tramadol hydrochloride SR Tablets (Drug)
Placebo Comparator: Placebos match to HR18042 and Tramadol hydrochloride SR Tablets
Placebo Comparator
干预措施: Placebos (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) within 4 hours after drug administration
时间窗: 0-4 hours after drug administration
次要结局
- Time from drug administration to the first use of rescue medication(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) within 6 hours, 8 hours and 12 hours after drug administration(0 - 6 hours, 8 hours and 12 hours after drug administration)
- the Differences of Pain Intensity (PID) from 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)
- Proportion of subjects who receive rescue therapy during the treatment period(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 using pain relief scale (PAR, ranging from 0-4, the larger the number, the more obvious the pain relief) within 4 hours, 6 hours, 8 hours, 12 hours after drug administration (SPAR)(0 - 4 hours, 6 hours, 8 hours and 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)
- Proportion of subjects who reach 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)
研究者
研究点 (1)
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