Two Formulations and Concentrations of Epinastine Nasal Spray Versus Azelastine Nasal Solution for Allergic Rhinitis
NCT ID: NCT01382654
Last Updated: 2015-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
131 participants
INTERVENTIONAL
2006-09-30
2006-10-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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epinastine 0.1%
nasal spray 2 sprays to each nostril for a total of 3 doses
epinastine 0.1%
nasal spray 2 sprays to each nostril for a total of 3 doses
epinastine 0.1% with taste masking agent
nasal spray 2 sprays to each nostril for a total of 3 doses
epinastine 0.1% with taste masking agent
nasal spray 2 sprays to each nostril for a total for a 3 doses
epinastine 0.2%
nasal spray 2 sprays to each nostril for a total of 3 doses
epinastine 0.2%
nasal spray 2 sprays to each nostril for a total of 3 doses
epinastine 0.2% with taste masking agent
nasal spray 2 sprays to each nostril for a total of 3 doses
epinastine 0.2% with taste masking agent
nasal spray 2 sprays to each nostril for a total of 3 doses
azelastine 0.1%
nasal spray 2 sprays in each nostril for a total of 3 doses
azelastine 0.1%
nasal spray 2 sprays to each nostril for a total of 3 doses
Interventions
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epinastine 0.1%
nasal spray 2 sprays to each nostril for a total of 3 doses
epinastine 0.1% with taste masking agent
nasal spray 2 sprays to each nostril for a total for a 3 doses
epinastine 0.2%
nasal spray 2 sprays to each nostril for a total of 3 doses
epinastine 0.2% with taste masking agent
nasal spray 2 sprays to each nostril for a total of 3 doses
azelastine 0.1%
nasal spray 2 sprays to each nostril for a total of 3 doses
Eligibility Criteria
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Inclusion Criteria
* history of SAR or PAR for 1 year
* mild symptoms
Exclusion Criteria
* respiratory tract infection within 14 days prior to screening
18 Years
70 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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033-102
Identifier Type: OTHER
Identifier Source: secondary_id
033-102
Identifier Type: -
Identifier Source: org_study_id
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