This Study Contains an Active Drug Treatment Group With Mometasone Furoate Nasal Spray and a Placebo (Dummy) Treatment Group for Seasonal Allergic Rhinitis (SAR). (Study P05073)(COMPLETED)
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|ClinicalTrials.gov Identifier: NCT00491504|
Recruitment Status : Completed
First Posted : June 26, 2007
Results First Posted : April 5, 2010
Last Update Posted : March 13, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting. Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will evaluate are: 1) changes in eye symptoms (ocular symptom severity score) after dosing 2) how long MFNS works in relieving the nose (nasal) and eye (ocular) symptoms after 7 daily doses, 3) measurements of nose (nasal) blockage (obstruction), and 4) measurements of the subject's opinion of the study drugs by asking different questions. This study is could last up to 53 days for some subjects.
|Condition or disease||Intervention/treatment||Phase|
|Seasonal Allergic Rhinitis||Drug: Mometasone Furoate Nasal Spray Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||310 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study Using Subjective and Objective Measures to Evaluate the Clinical Efficacy of Mometasone Furoate Nasal Spray (MFNS) Following Initial and Maintenance Dosing in Subjects With Allergen-Induced Seasonal Allergic Rhinitis (SAR) in an Environmental Exposure Chamber (EEC)|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
Experimental: Mometasone Furoate Nasal Spray (MFNS)
MFNS 200 mcg total dose (2 sprays each nostril)
Drug: Mometasone Furoate Nasal Spray
Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg)
Other Name: SCH 032088
Placebo Comparator: Placebo
Placebo (2 sprays each nostril)
Placebo: 2 sprays in each nostril
Primary Outcome Measures :
- Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1 [ Time Frame: Baseline and 6 hours following initial dosing ]Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea & itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, & disturbing some of the time; 3=Severe: sign/symptom very noticeable & very bothersome most of the time.
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