Health Condition 1: J309- Allergic rhinitis, unspecified
Conditions
Interventions
Intervention1: FDC of Fexofenadine 60 mg plus Montelukast 4 mg Oral Suspension: Patients will be advised to take 5 mL of oral suspension once a day orally one hour before or two hours after meals arou
Sponsors
Synokem Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged between 6 and 11 years (both inclusive). 2. Patients with a history of allergic rhinitis, a positive skin prick test to at least one relevant allergen and active symptoms of allergic rhinitis at study entry. 3. Patients with elevated serum IgE levels ( >100 IU/mL) at screening or baseline visit. 4. Patients with Total Nasal Symptom Score (TNSS) at screening or baseline >= 4. 5. Patients with ability to understand and provide oral assent in the presence of parent / legally acceptable representative, which must have been obtained prior to screening. 6. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity to either of the study medications or any of the ingredients of the formulation. 2. Patients with Electrocardiographic abnormalities including conduction delay and an abnormal QTc interval. 3. Patients with upper respiratory tract infections including cold and systemic infections within 3 weeks of baseline/screening visit. 4. Patients with history of renal, hepatic, gastrointestinal tract, cardiovascular, respiratory, haematological, endocrine or neurological diseases. 5. Patients with clinically significant impaired hepatic function [SGOT & SGPT more than 2.5X the UNL]. 6. Patients who had initiation of allergen immunotherapy within previous 6 months. 7. Patients with history of Rhinitis medicamentosa, non-allergic rhinitis or substantial structural nasal obstruction. 8. Patients with history of nasal polyps or any clinically important nasal anomaly. 9. Patients with history of acute and/or chronic sinusitis within 30 days of baseline/screening visit. 10. Patients with history of eye surgery or intranasal surgery within 3 months of baseline/screening visit. 11. Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 months before the trial. 12. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to screening visit. 13. Patients currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period. 14. Suspected inability or unwillingness to comply with the study procedures. 15. Patients with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Total Symptom Score [(TSS is the sum Total nasal symptom score (TNSS) and Total Non-Nasal symptom score (TNNSS)] at the end of study as compared to baseline.Timepoint: At Screening Visit (Visit 1), Day 7 (Visit 3) and Day 14 (Visit 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and Serious adverse events reported during the study.Timepoint: Throughout the study.;Changes in clinical laboratory parameters from baseline to end of the study visit.Timepoint: At Screening Visit (Visit 1) and Day 14 (Visit 4);Mean change in Total nasal symptom score (TNSS) at the end of study as compared to baseline.Timepoint: At Screening Visit (Visit 1), Day 7 (Visit 3) and Day 14 (Visit 4);Mean change in Total non-nasal symptom score (TNNSS) at the end of study as compared to baseline.Timepoint: At Screening Visit (Visit 1), Day 7 (Visit 3) and Day 14 (Visit 4) | — |
Countries
India
Contacts
Public ContactMr Surender Kumar Arora
Clinwave Research Pvt. Ltd.
Outcome results
None listed