CTRI/2011/07/001877招募中3 期
A comparative, multi-center, open label, randomized, parallel group Efficacy and Safety Study of Benzonatate 100 mg soft gel capsule for the symptomatic treatment of acute non-productive cough
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Biocon Ltd
- 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
- •i)Patients willing to provide written informed consent to participate in the study
- •ii)Male and Female patient in the age range of 10-65 years.
- •iii)Patients with acute (defined as less than 3 week duration) non-productive cough presenting in out patient setting.
- •iv)Patients with a baseline daytime cough symptom score of at least 2.
- •v)Patients must be literate so that no one of them should chew the soft gel capsule inside the mouth which may be dangerous.
排除标准
- •i)Female patients of child bearing potential or male study patient who has a partner of childbearing potential, who refuses to use a medically acceptable form of contraception throughout the study.
- •ii)Female patient who is pregnant or lactating.
- •iii)Patients with chronic cough (cough 3 weeks duration)
- •iv)Patients or with clinically suspected lower respiratory tract infection (e.g. pneumonia tuberculosis), asthma or having incidences of self-reported wheeze, chronic obstructive pulmonary disease with history any concurrent airway disease (eg. tonsillitis, sinusitis, deviated nasal septum, polyps etc.)
- •v)Patients taking any other antitussives, sleeping pills, sedative medications, or herbal cough remedies;
- •vi)Patients with history of allergy to local anesthetics or topical anesthetics of the para-amino- benzoic acid class (e.g. procaine; tetracaine; benzocaine) or other ester-type local anesthetics.
- •vii)Patients currently on any treatments that may influence cough.
- •viii) Patient has hepatic insufficiency or at screening presents with AST or ALT 2 times the upper limit of normal (ULN) or bilirubin 1.5 times the ULN.
- •ix)Patients with renal impairment or at screening presents with serum creatine 1.4 mg/dL or Blood Urea 40 mg/dL.
- •x)Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, psychiatric, or hematological disease as determined by the clinical judgment of the investigator;
- •xi)Use of any investigational drug or participation of any clinical trial within 30 days prior to this study.
研究者
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