EUCTR2004-004113-42-GB进行中（未招募）1 期
SCH 486757 vs Codeine and Placebo in Subjects with Persistent Postviral Cough
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Sufficiently symptomatic- cough severity score of at least moderate at Visit 2 (Screening).
- •Must have had signs and symptoms indicative of a viral upper respiratory infection with an onset of at least 14 days, but not more than 90 days prior to the Pre-Screening Visit (Visit 1)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnancy/Lactation
- •Use of concurrent prohibited medications unless they observe the washout period prior to the Screening and Baseline Visits (Visits 2 and 3). (including opioid- and non-opioid-containing cough suppressants, proton pump inhibitors, H2 receptor antagonists and potent CYP3A inhibitors, such as ritonavir, ketoconazole, and clarithromycin). Subjects receiving ACE inhibitors or MAOIs will be excluded from the study.
- •Asthma or chronic obstructive pulmonary disease that requires chronic use of inhaled or systemic corticosteroids current or history of frequent clinically significant sinusitis or chronic purulent postnasal drip. history of allergies to more than two classes of medications or with an allergy to Lycra®.
- •Current smokers, ex-smokers who stopped smoking in the previous 6 months, or subjects with a cumulative smoking history >10 pack-years will
- •be excluded.
- •Subjects with current gastroesophageal reflux disease.
研究者
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