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
- 试验地点
- 3
- 主要终点
- Change in the daytime cough symptom scores at end of 5 days (120 hrs) of first examination as compared to the baseline.
研究概览
简要总结
This study is to compare efficacy and safety of benzonatate 100 mg soft gel capsule for the symptomatic treatment of acute non-productive cough. The Study agent is benzonatate100 mg soft gel capsule taken (swallow) thrice every day and the comparator agent is dextromethorphan 10mg doses every 4 hours or 30 mg every 6 hours (as prescribed by the physician). The study will be conducted on 200 patients in 3 different centers in India for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 10.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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
- •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.
结局指标
主要结局
Change in the daytime cough symptom scores at end of 5 days (120 hrs) of first examination as compared to the baseline.
时间窗: 5 days
次要结局
- Reduction in day and night time cough scores on days 5-7 as compared to baseline(5-7 Days)
- Change in Night time score from the baseline at end of 5 days (120 hrs) of first examination as compared to the baseline(5 Days)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
4 期
Belatacept Early Steroid Withdrawal TrialRenal TransplantationNCT01729494University of Cincinnati316
已完成
2 期
Probenecid (PB) to Treat Hereditary Nephrogenic Diabetes Insipidus (NDI), ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium AdministrationAcquired Nephrogenic Diabetes InsipidusCongenital Nephrogenic Diabetes InsipidusNephrogenic Diabetes InsipidusAutosomal Dominant Polycystic Kidney DiseaseNCT05190744Mayo Clinic36
终止
3 期
Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson DiseaseWilson DiseaseNCT05047523Alexion Pharmaceuticals, Inc.40
已完成
4 期
Efficacy and Tolerability of an Innovative Formulation of BAK-free LatanoprostPrimary Open-angle GlaucomaNCT03331770Laboratorios Poen103
已完成
3 期
An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)Rhinitis, Allergic, SeasonalAsthma, BronchialNCT00092885Organon and Co831