Clinical Trial: A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Dose Finding and Dose Regimen Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis
Brief Summary: This is a multicenter, randomized, double-blind within the dose level, parallel group comparison of mometasone furoate nasal spray in subjects with perennial allergic rhinitis to examine the minimal effective dose, the recommended dose, and the dosing regimen.
Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: Change in 4 nasal symptom score (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) from baseline at Week 2 [ Time Frame: After 2 weeks of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in each nasal symptom (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) [ Time Frame: After 1 and 2 weeks of treatment ]
- Overall improvement [ Time Frame: After 1 and 2 weeks of treatment ]
- QOL score [ Time Frame: At initial day of treatment and after 2 weeks of treatment ]
- Adverse events [ Time Frame: From initial day of treatment until 7-10 days after treatment is stopped. ]
- Laboratory tests [ Time Frame: From initial day of treatment until treatment is stopped. ]
Original Secondary Outcome: Same as current
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: October 23, 2008
Date Started: April 8, 2004
Date Completion:
Last Updated: May 10, 2017
Last Verified: May 2017
