Health Condition 1: null- Patients suffering from acute non-productive cough
Conditions
Interventions
Intervention1: Benzonatate 100 mg soft gel capsule: one soft gel capsule taken (swallow) thrice daily
Control Intervention1: Dextromethorphan 10mg: every 4 hours
Control Intervention2: Dextromethorpha
Sponsors
Biocon Ltd
Bioequivalence Study Centre
TAAB Biostudy Services
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Vanita Sabhait
Outcome results
None listed