CTRI/2009/091/000639已完成3 期
An open label, comparative, multicentric study to assess the efficacy and safety of Zileuton extended-release tablets in comparison with Montelukast sodium tablets in patients suffering from bronchial asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients between 18-65 years of age
- •2.Patients with an established diagnosis of mild to moderate chronic persistent bronchial asthma
- •3.Informed consent of the patient/relative
排除标准
- •1.Pregnancy and/or lactation
- •2.Patients with severe or unstable bronchial asthma or having acute asthmatic attack at the time of enrolment
- •3.Patients with a clinically relevant respiratory tract infection in the four weeks prior to enrolment
- •4.Patients with liver dysfunction i.e., active liver disease or persistent hepatic function enzyme elevations ≥3 times the upper limit of normal
- •5.Patients with any other clinically significant illness
- •6.Patients with a history of hypersensitivity to any of the components of the study medications
- •7.Patients with any other serious concurrent illness or malignancy
- •8.Patients with continuing history of alcohol and / or drug abuse
- •9.Participation in another clinical trial in the past 3 months
研究者
相似试验
已完成
4 期
The aim of this study is to determine the efficacy, safety and ease of use of Lidocaine Lozenges for the patient undergoing gastrointestinal endoscopy as compared to lidocaine spray.CTRI/2010/091/001217Troikaa Pharmaceuticals Ltd Ahmedabad250
已完成
3 期
A clinical trial to study the effects of two drugs, fixed dose combination capsules of Telmisartan & Indapamide (as sustained release) and Telmisartan tablets in patients with hypertension.CTRI/2009/091/000863Cadila Healthcare Ltd200
已完成
3 期
A clinical trial to study fixed dose combination of Formoterol fumarate & Mometasone furoate dry powder inhaler and fixed dose combination of Formoterol fumarate & Budesonide dry powder inhaler in patients with bronchial asthma and/or chronic obstructive pulmonary disease (COPD).CTRI/2009/091/000111Cadila Healthcare Ltd200
已完成
3 期
A clinical trial to study the effects of two drugs, fixed dose combination tablets of Etodolac & Tolperisone hydrochloride and Tolperisone hydrochloride tablets in patients with musculoskeletal disorders associated with painful muscle spasm.CTRI/2009/091/001021Cadila Healthcare Ltd200
已完成
3 期
A clinical trial to study the effects of two drugs, fixed dose combination tablets of Nebivolol & Indapamide (as sustained release) and Nebivolol tablets in patients with hypertensioCTRI/2009/091/000683Cadila Healthcare Ltd200