NCT01416480已完成3 期
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule 300mg" as an Antitussive Agent in Acute Cough Patients.
Ahn-Gook Pharmaceuticals Co.,Ltd1 个研究点 分布在 1 个国家目标入组 332 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- cough remission rate
研究概览
简要总结
The aim of this clinical trial is to evaluate the antitussive effect of "Theobromine capsule 300mg" in patients with acute bronchitis.
详细描述
This study is double blinded, randomized, parallel designed, phase III clinical trial to evaluate the efficacy and safety of "Theobromine capsule 300mg" versus "Levodropropizine syrup" in patients with acute bronchitis.
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
- •Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
- •Adult aged over 18
- •Patient who has cough symptom caused by acute bronchitis
- •Patient who go to see the doctor for severe cough at his(her) own will
- •DCS score at screening vist sould be over
- •For fertile woman, HCG test at screening visit shloud be negative.
- •patient who will continue to cough more than 1 week.(by physician's judgment)
排除标准
- •Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis, asthma.
- •Chronic bronchitis including bronchial obstruction
- •Patient who has clinical history of sensitivity to Xanthine drug.
- •Patient who has Peptic Ulcer
- •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 convulsion or alcoholism.
- •Patient who has experience to have participated in other clinical trial within two months before starting the trial.
- •Pregnant woman, lactating woman.
- •Patient who thought to be cured within 3 days without any medicine.
研究组 & 干预措施
Theobromine
Experimental
Theobromine capsule 300mg
干预措施: Theobromine 300mg (Drug)
levodropropizine
Active Comparator
levodropropizine syrup
干预措施: Levodropropizine 10mg (Drug)
结局指标
主要结局
cough remission rate
时间窗: 3 days
cough remission : no cough or 1 short cough in day time
次要结局
- cough recovery rate(1 day, 2 days, within 3days)
- difference of DCS score between screening and closing visit.(3 days)
- required time for cough remission(3 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Effect of Tiotropium Inhalation Capsules (Spiriva) on Exercise Tolerance in COPD PatientsPulmonary Disease, Chronic ObstructiveNCT00157235Boehringer Ingelheim234
已完成
3 期
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Moderate Persistent AsthmaAsthmaNCT01634139Boehringer Ingelheim403
已完成
3 期
Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent AsthmaAsthmaNCT01634152Boehringer Ingelheim401
已完成
3 期
Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent AsthmaAsthmaNCT01277523Boehringer Ingelheim392
已完成
4 期
Study to Evaluate the Effects of Tiotropium Bromide on Chronic Obstructive Pulmonary Disease (COPD) During ExerciseCOPDNCT00412204McMaster University20