NCT00380315已完成3 期
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 Capsule as an Anti-Tussive Agent in Cough Patients: Double Blinded, Randomized, Placebo and Active Rug Comparative, Parallel Designed Phase III Study
Ahn-Gook Pharmaceuticals Co.,Ltd2 个研究点 分布在 2 个国家目标入组 396 人开始时间: 2006年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 396
- 试验地点
- 2
- 主要终点
- Cough severity, Cough specific Quality of Life
研究概览
简要总结
This study is for therapeutic confirmation of AG1321001 to evaluate the safety and efficacy as an anti-tussive agent in cough patients.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult between the ages of 18 and
- •Patient who has cough symptom caused by following diseases: chronic bronchitis, bronchiectasis, gastroesophageal reflux disease, postnasal drip syndrome caused by rhinitis, sinusitis, rhinopharyngitis, rhinolaryngitis.
- •Patient requiring internal treatment due to cough symptom, who has coughing more than 3 weeks.
- •patient who will continue to cough more than 1 week.(by physician's judgment)
- •Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
- •Patient who is trustworthy, ready for cooperation and observing the restrictions during the trial period.
排除标准
- •Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis.
- •Patient who has clinical history of sensitivity to Xanthine drug.
- •Patient who has Peptic Ulcer or Asthma (Except Cicatrix)
- •Patient whose liver or kidney function is seriously abnormal: Including the cases of sGOT, sGPT, bilirubin and blood creatinine value exceeding twice of their upper normal limit.
- •Patient whose heart function is abnormal: including the case of showing abnormal EKG test value that is clinically significant.
- •Patient who has experience to have participated in other clinical trial within two months before starting the trial.
- •Pregnant woman, lactating woman.
- •patient who has convulsion or alcoholism.
- •patient who take medicines which can not use combination with AG1321001.
结局指标
主要结局
Cough severity, Cough specific Quality of Life
次要结局
- Daily cough symptom, Cough frequency
研究者
研究点 (2)
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