NCT00954356已完成2 期
Single-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Evaluate the Safety, PK, & Efficacy of a Single Oral Dose of XPF-001 in the Treatment of Pain Related to Third Molar/Wisdom Tooth Extraction.
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
- 61
- 试验地点
- 1
- 主要终点
- Total Pain Relief at 6 Hours Post Dose (TOTPAR 6)
研究概览
简要总结
The purpose of this trial is to determine if XPF-001 is effective for the treatment of pain following third-molar/wisdom tooth extraction.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males (aged 18-60) and females of non-childbearing potential (aged 18-60;
- •BMI between 19.5 to 32.0 kg/m2;
- •Outpatient, scheduled to undergo surgical extraction of 2 or more impacted 3rd molars (with at least 1 partial bony mandibular extraction);
- •use of only the following preoperative medications 2% lidocaine with epinephrine and nitrous oxide;
- •Able to complete the requested information on analgesic questionnaires and able to comply with study procedures and restrictions;
- •Able to read, comprehend and sign the consent form;
- •Deemed medically healthy to participate in the study, with normal or clinically insignificant medical history, physical examination, lab tests and ECG results;
- •No contraindications to the study drug, it excipients or any of the study medications including rescue medications.
排除标准
- •Presence of a clinically significant medical condition;
- •Positive test for HIV, Hepatitis B or Hepatitis C;
- •Use of any prescription or over the counter medication or supplement in the 48 hours before dose of study drug until discharge;
- •Acute local infection at the time of dental surgery;
- •Females who are pregnant, lactating or of child-bearing potential, or who provide a positive pregnancy test result at screening or check-in;
- •Males not undertaking adequate measures to prevent their partner becoming pregnant throughout the study;
- •Clinically significant laboratory values;
- •Clinically significant abnormal ECG;
- •History or presence of alcoholism, or alcohol or substance abuse (within previous 2 years), or routine consumption of 3 or more alcoholic drinks per day;
- •A positive urine drug test;
- •Routine use of analgesics 5 or more times per week;
- •Presence or history (within 2 years of enrolment) of bleeding disorder(s) or peptic ulcer disease;
- •History of allergic reaction to any drug, including penicillin;
- •Ingestion of caffeine containing foods or drinks in the 24 hours before dose of study drug;
- •Consumption of alcohol in the 48 hours before dose of study drug, or a positive alcohol breath test at check-in;
- •Consumption of grapefruit or grapefruit containing products in the 7 days before dose of study drug;
- •Use of tobacco or nicotine substitutes within 1 month of dose of study drug, or inability to refrain from use of nicotine between check-in and follow up;
- •Treatment for depression in the 6 months prior to enrolment;
- •Use of another investigational drug in the 60 days before enrolment;
- •Donation or loss of 50-500 mL of blood in the 30 days prior to enrolment, or more than 500 mL of blood in the 56 days before enrolment;
- •Previously entered into this study;
- •Study site or Sponsor employees or relatives of employees directly involved in the study;
- •Any other condition that (in the opinion of the Investigator or sponsor) makes the subject unsuitable for the study.
研究组 & 干预措施
XPF-001
Experimental
干预措施: XPF-001 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Total Pain Relief at 6 Hours Post Dose (TOTPAR 6)
时间窗: 6 hours post dose
The primary efficacy variable was total pain relief at the 6-hour observation (TOTPAR 6); TOTPAR 6 is an area calculation incorporating time and relief scores over the 6 hours following dosing and was calculated using Simpson's trapezoidal rule. The higher the LS Means scores, the more pain relief was obtained. Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 6 score = 0, maximum possible score = 24
次要结局
- Total Pain Relief (TOTPAR) at 4 Hours Post Dose(4 hours)
- Time to Meaningful Relief(24 hours)
- Summed Pain Intensity Difference (SPID) at 8 Hours Post Dose(Baseline to 8 hours post dose)
- Time to First Perceptible Relief(24 hours)
- Treatment Emergent Adverse Events(48 hours)
- Total Pain Relief (TOTPAR) at 12 Hours Post Dose(12 hours)
- Summed Pain Intensity Difference (SPID) at 4 Hours Post Dose(Baseline to 4 hours post dose)
- Summed Pain Intensity Difference (SPID) at 12 Hours Post Dose(Baseline to 12 hours post dose)
- Time to Rescue Medication(24 hours)
- Total Pain Relief (TOTPAR) at 8 Hours Post Dose(8 hours)
- Summed Pain Intensity Difference (SPID) at 6 Hours Post Dose(Baseline to 6 hours post dose)
研究者
研究点 (1)
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