A Bi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of STAHIST in Adult Subjects With a History of Seasonal Allergic Rhinitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Total Symptom Scores(TSS)reported and compared between the two study arms
研究概览
简要总结
To report and compare total symptom scores, nasal symptom scores, post-nasal drip symptom scores, and adverse reactions in and between SAR subjects on active drug and SAR subjects on placebo.
详细描述
This double-blind, placebo-controlled study will evaluate the efficacy and safety of STAHIST vs. placebo over a 2-week period in 100 study subjects with a history of SAR for at least two years. The study will take place in two sites, Louisville, KY and South Bend, IN. SAR symptoms to be scored and compared include: nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip.
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
- 否
入选标准
- •Males and females of any ethnic group between 18 and 60 years of age.
- •History of moderate to severe SAR for at least two years.
- •Subjects' symptoms resulting from the irritation of sinus, nasal and upper respiratory tract tissues will include the five symptoms that are th focus of this study: nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip. Subjects must have a TSS baseline score of at least 8 on the S5 Subject Diary.
- •Prior to study drug administration, subjects' good health will be confirmed by medical history and physical examination, including pregnancy test (urine dip) before study inception.
- •Allergic hypersensitivity will be confirmed by the physician or well established patient medical history.
- •Subject's compliance with requisite run-in period for each subject will be confirmed by investigator/designee.
排除标准
- •Pregnancy or lactation.
- •Immunotherapy unless at a stable maintenance dose.
- •Presence of a medical condition that might interfere with treatment evaluation or require a change in therapy including but not limited to high blood pressure or urinary retention problems.
- •Alcohol dependence.
- •Use of any other investigational drug in the previous month.
- •Subjects presenting with asthma requiring corticosteroid treatment.
- •Subjects with multiple drug allergies.
- •Subjects known to have an idiosyncratic reaction to any of the ingredients in IMP (STAHIST).
- •Subject who is participating in any other clinical study.
- •Subject who is unable to meet washout requirements.
- •Subject with clinically significant abnormal vital sign or laboratory value that precludes participation.
- •Subject with any family relationship to the sponsor, investigator, or staff of sponsor or investigator.
- •A URI within 4 weeks of study inception.
- •Subjects taking beta blockers or try-cyclic antidepressants. -
研究组 & 干预措施
Placebo
Placebo containing no active pharmaceutical ingredients
干预措施: Placebo (Drug)
STAHIST
STAHIST tablet for the symptomatic treatment of Seasonal Allergic Rhinitis
干预措施: STAHIST (Drug)
结局指标
主要结局
Total Symptom Scores(TSS)reported and compared between the two study arms
时间窗: Twice daily over the 2 week study period
TSS includes the sum of nasal congestion, rhinorrhea, nasal itching, sneezing, and post-nasal drip
次要结局
- Adverse events--report and assess(Continuous over the two week study period)