Onset of Effect of Mometasone Nasal Spray in Induced Allergic Rhinitis (Study P03431)
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|ClinicalTrials.gov Identifier: NCT00783237|
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : March 23, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This was a single-dose study to determine the time it takes for mometasone furoate nasal spray to go in effect, after a single dose of 2 sprays per nostril. Patients who are eligible were exposed to ragweed pollen for 3 hours on one or two occasions. Patients who experienced adequate symptoms during the pollen exposure phase came back for a Treatment Phase visit. During the Treatment Phase visit, patients were exposed to ragweed pollen for 2 hours and then received either mometasone or placebo nasal spray. Symptom evaluations began on the patients every hour for the next 11 hours.
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis||Drug: Mometasone Drug: Placebo||Phase 4|
Merck Sharp & Dohme Corp. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Onset of Action of Mometasone Furoate Nasal Spray vs. Placebo in Induced Allergic Rhinitis|
|Actual Study Start Date :||December 1, 2003|
|Actual Primary Completion Date :||February 21, 2004|
|Actual Study Completion Date :||February 21, 2004|
|Experimental: Mometasone Furoate Nasal Spray||
Mometasone Furoate Nasal Spray, single dose of 200 mcg (2 sprays per nostril)
Other Name: Nasonex, SCH 032088
|Placebo Comparator: Placebo Nasal Spray||
Placebo nasal spray, single dose of 2 sprays per nostril
Primary Outcome Measures :
- Total Nasal Symptom Score (TNSS) [ Time Frame: On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours ]
Secondary Outcome Measures :
- Nasal and Non-Nasal symptoms, Total Nasal and Total Non-Nasal symptoms, Total Symptom Score, Global Therapeutic Response [ Time Frame: On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours ]
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