drugset / Trial / NCT01382654

Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis

NCT01382654

Phase 2 Completed 131 enrolled Merck Sharp & Dohme LLC
RandomizedCrossoverQuadruple-blindTreatment

Summary

The objectives of this study were to: * Examine the tolerability of two formulations and two dose concentrations of epinastine. * Select formulation(s) of epinastine for future studies by evaluating the individual sensory attribute scores of the Nasal Spray Evaluation Questionnaire (NSEQ) collected after each study drug administration and the subject preference ranking assessed at the completion of the study. * Compare the preference of two formulations and two dose concentrations of epinastine compared to azelastine following a single dose of each in a randomized, double-blind, two-cohort, three-period crossover design.

Timeline

Start
2006-09
Primary completion
2006-10
Completion
2006-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azelastine Small molecule 0.1 % Intranasal
Subject Epinastine Small molecule 0.1 % Intranasal
Subject Epinastine Small molecule 0.2 % Intranasal

Indications