A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604)
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|ClinicalTrials.gov Identifier: NCT01386125|
Recruitment Status : Completed
First Posted : June 30, 2011
Results First Posted : December 19, 2013
Last Update Posted : April 13, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This study will evaluate the effectiveness and safety of MFNS in improving nasal congestion/obstruction and in reducing bilateral nasal polyps.
|Condition or disease||Intervention/treatment||Phase|
|Nasal Polyps||Drug: Mometasone Furoate Nasal Spray (MFNS) Drug: Placebo for MFNS||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||748 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) in the Treatment of Nasal Polyps (Protocol No. P05604)|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Experimental: Mometasone Furoate Nasal Spray (MFNS)
Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks
Drug: Mometasone Furoate Nasal Spray (MFNS)
MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks
Placebo Comparator: Placebo
Participants receive matching placebo nasal spray BID for 16 weeks
Drug: Placebo for MFNS
Two sprays in each nostril BID for up to 16 weeks
Primary Outcome Measures :
- Change From Baseline in Congestion/Obstruction Score [ Time Frame: Baseline and Weeks 1-4 ]At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline.
- Change From Baseline in Total Polyp Size Score [ Time Frame: Baseline and Week 16 ]An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline.
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