The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)
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|ClinicalTrials.gov Identifier: NCT00092118|
Recruitment Status : Completed
First Posted : September 24, 2004
Results First Posted : July 23, 2010
Last Update Posted : June 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Rhinitis, Allergic, Perennial||Drug: Montelukast Drug: Comparator: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1992 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis|
|Study Start Date :||October 2003|
|Primary Completion Date :||May 2004|
|Study Completion Date :||May 2004|
one 10 mg tablet, taken once daily at bed time for 6 weeks
Placebo Comparator: 2
Drug: Comparator: Placebo
one placebo tablet, taken once daily at bed time for 6 weeks
- Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis [ Time Frame: 6 week treatment period (from baseline though the end of week 6) ]Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale [Score 0 (best) to 3 (worst)].
- Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period [ Time Frame: At the end of the 6 week treatment period ]An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], in answer to a single question regarding the change in symptoms as compared to the beginning of the study.
- Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period [ Time Frame: Baseline and Week 6 ]Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale [Score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092118
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|