Clinical Trial: WAL801CL (Epinastine Hydrochloride) Dry Syrup in Paediatric Perennial Allergic Rhinitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase III Double-blind Comparative Study of WAL801CL Dry Syrup in Paediatric Perennial Allergic Rhinitis
Brief Summary: Study to investigate the efficacy of WAL801CL Dry Syrup in comparison with ketotifen fumarate on pediatric perennial allergic rhinitis and to evaluate the safety of WAL801CL Dry Syrup compared to ketotifen fumarate and to confirm the appropriateness of dosage of WAL801 Dry Syrup.
Detailed Summary:
Sponsor: Boehringer Ingelheim
Current Primary Outcome: Total severity scores of nasal symptoms judged by the physician [ Time Frame: 2 weeks of first administration of study drug ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Severity score for each nasal symptom given by the physician [ Time Frame: 2 weeks of first administration of study drug ]
- Nasal symptom score in the diary [ Time Frame: 2 weeks ]
- Total scores for nasal symptoms in the diary [ Time Frame: 2 weeks of first administration of study drug ]
- Severity score for allergic rhinitis according to the Allergic Rhinitis Severity Classification [ Time Frame: 2 weeks ]
- Impression of the patient or the parent [ Time Frame: week 2 after first administration of study drug ]
- Occurrence of adverse events [ Time Frame: up to 2 weeks after administration of study drug ]
- Number of patients with abnormal changes from baseline in laboratory tests (hematology, biochemistry, urinalysis) [ Time Frame: Baseline and week 2 ]
Original Secondary Outcome: Same as current
Information By: Boehringer Ingelheim
Dates:
Date Received: July 2, 2014
Date Started: June 2001
Date Completion:
Last Updated: July 11, 2014
Last Verified: July 2014
