Clinical Trial: Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study on Efficacy and Safety of Mometasone Furoate Nasal Spray (MFNS) in the Post Surgical Treatment of Nasal Polypos
Brief Summary: This study was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps. Patients who met Screening eligibility underwent endoscopic sino-nasal surgery (FESS) on visit 2. Mometasone nasal spray or placebo was started about 2 weeks after surgery and continued for up to 24 weeks or until relapse.
Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: Time to relapse in polyp score after surgery [ Time Frame: Assessment for relapse was performed at every study visit (up to 24 weeks of treatment) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Signs and symptom scores [ Time Frame: All study visits (up to 24 weeks of treatment) ]
- Quality of life, peak nasal inspiratory flow, olfaction threshold [ Time Frame: Measured starting 1 week after treatment up to 24 weeks of treatment ]
- Adverse events [ Time Frame: Throughout the whole study after the Screening period. ]
Original Secondary Outcome: Same as current
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: August 5, 2008
Date Started: September 1, 2003
Date Completion:
Last Updated: March 21, 2017
Last Verified: March 2017
