Health Condition 1: J989- Respiratory disorder, unspecified
Conditions
Interventions
Intervention1: FDC OF Bilastine 3.3 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg per 5 mL: Dosage Form: Syrup
Dose: A single dose will consist of 10 mL of syrup
Dosage Frequency: Thrice dail
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age at least 12 years (completed) and less than 65 years (subjects who completed 65th birthday will be excluded) at the time of signing consent/assent. 2. Provided written informed consent (pediatric assent and parental consent in case of children 3. Male or female subjects with acute cough of less than 7 days duration at the time of consent, associated with common cold or allergy. 4. Cough severity at least 60 mm on visual analogue scale (VAS) at screening. 5. Willing and able to comply with all aspects of the protocol. 6. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pre-treatment urine pregnancy test 7. Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment.
Exclusion criteria
Exclusion criteria: 1.A productive cough with excessive secretions, regardless of colour. 2.Subjects with chronic cough (i.e. history of chronic bronchitis in smokers, gastro ?esophageal reflux, asthma, hyper ?responsive airways after resolution of respiratory tract infection, COPD, pertussis, aspiration, tumor, tuberculosis or fungal infections). 3.Subjects receiving oral or intranasal anti-histamine or cough suppressant or decongestant within 7 days prior to screening. 4.Subjects taking angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) within 14 days of consent 5.Pregnant or breastfeeding. 6.Positive urine pregnancy test at screening. 7.Known hypersensitivity to the study drugs (investigational product or comparator) or any of the excipients. 8.Subjects with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the subject’s participation in the study. 9.Previous participation in another interventional clinical study within 30 days of first dose in this study. 10.Concurrent enrolment in another interventional clinical study. 11.Employee of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals. 12.Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results. 13.Subjects with history of significant cardiovascular disease, uncontrolled hypertension, uncontrolled diabetes mellitus, closed angle glaucoma, hyperthyroidism, prostatic enlargement or phaeochromocytoma at screening. 14. Subjects receiving monoamine oxidase inhibitor, a selective serotonin reuptake inhibitor, or other medications for depression, psychiatric, or emotional conditions, or Parkinson s disease with within 14 days prior to consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Day 4 in cough severity on a 100 mm Visual Analogue Scale (VAS)Timepoint: From baseline to Day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse eventsTimepoint: From the start to end of study;Change from baseline to Day 4 and 8 in cough frequency on a 100 mm VASTimepoint: From Baseline to Day 4 and Day 8;Change from baseline to Day 4and 8 in sleep deprivation on a 100 mm VASTimepoint: From Baseline to Day 4 and Day 8;Change from baseline to Day 8 in cough severity on a 100 mm VASTimepoint: From baseline to Day 8;Drowsiness score on Profile of Mood State (POMS) questionnaireTimepoint: From Baseline to end of study;Investigator Global Impression of Change (IGIC) on Day 4 and 8Timepoint: On Day 4 and Day 8;Patient Global Impression of Change (PGIC) on Day 4 and 8Timepoint: On Day 4 and Day 8;Proportion of subjects with complete clinical cure on Day 4 and 8Timepoint: On Day 4 and Day 8;Proportion of subjects with resolution of cough symptoms on Day 4 and 8Timepoint: On Day 4 and Day 8 | — |
Countries
India
Contacts
Public ContactAmol Pendse
Glenmark Pharmaceuticals Ltd
Outcome results
None listed