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
- Conditions
- Health Condition 1: null- Patients suffering from acute non-productive cough
- Registration Number
- CTRI/2011/07/001877
- Lead Sponsor
- Biocon Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 200
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the daytime cough symptom scores at end of 5 days (120 hrs) of first examination as compared to the baseline.Timepoint: 5 days <br>
- Secondary Outcome Measures
Name Time Method Change in Night time score from the baseline at end of 5 days (120 hrs) of first examination as compared to the baselineTimepoint: 5 Days;Reduction in day and night time cough scores on days 5-7 as compared to baselineTimepoint: 5-7 Days