Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117) | RxWiki

Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)

Overview[ - collapse ][ - ]

Purpose	This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.
Condition	Seasonal Allergic Rhinitis
Intervention	Drug: Comparator: montelukast/loratadine Drug: Comparator: montelukast Drug: Comparator: loratadine Drug: Comparator: placebo
Phase	Phase 3
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT00963599
First Received	August 19, 2009
Last Updated	February 27, 2014
Last verified	February 2014

Tracking Information[ + expand ][ + ]

First Received Date	August 19, 2009
Last Updated Date	February 27, 2014
Start Date	September 1999
Estimated Primary Completion Date	November 1999
Current Primary Outcome Measures	Mean Change From Baseline in Daytime Nasal Symptoms Score [Time Frame: Baseline and Week 2] [Designated as safety issue: No]Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
Current Secondary Outcome Measures	Mean Change From Baseline in Nighttime Symptoms Score [Time Frame: Baseline and Week 2] [Designated as safety issue: No]Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) [Time Frame: Baseline and Week 2] [Designated as safety issue: No]Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)). Mean Change From Baseline in Daytime Eye Symptoms Score [Time Frame: Baseline and Week 2] [Designated as safety issue: No]Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Mean Change From Baseline in Daytime Nasal Congestion Score [Time Frame: Baseline and Week 2] [Designated as safety issue: No]Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)). Mean Change From Baseline in Daytime Rhinorrhea Score [Time Frame: Baseline and Week 2] [Designated as safety issue: No]Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)). Mean Change From Baseline in Daytime Nasal Itching Score [Time Frame: Baseline and Week 2] [Designated as safety issue: No]Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)). Mean Change From Baseline in Daytime Sneezing Score [Time Frame: Baseline and Week 2] [Designated as safety issue: No]Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). Mean Change From Baseline in Nasal Congestion Upon Awakening [Time Frame: Baseline and Week 2] [Designated as safety issue: No]Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)). Patient's Global Evaluation of Allergic Rhinitis [Time Frame: Week 2] [Designated as safety issue: No]An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse). Physician's Global Evaluation of Allergic Rhinitis [Time Frame: Week 2] [Designated as safety issue: No]An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse). Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score [Time Frame: Week 2] [Designated as safety issue: No]Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score.

Descriptive Information[ + expand ][ + ]

Brief Title	Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)
Official Title	A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Combination Montelukast/Loratadine in Patients With Seasonal Allergic Rhinitis-Fall Study
Brief Summary	This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Seasonal Allergic Rhinitis
Intervention	Drug: Comparator: montelukast/loratadine montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks Drug: Comparator: montelukast montelukast 10 mg tablet taken once daily at bed time for 2 weeks Drug: Comparator: loratadine loratadine 10 mg tablet taken once daily at bed time for 2 weeks Drug: Comparator: placebo placebo tablet taken once daily at bed time for 2 weeks
Study Arm (s)	Experimental: 1 montelukast/loratadine Experimental: 2 loratadine Experimental: 3 montelukast Placebo Comparator: 4 placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	907
Estimated Completion Date	November 1999
Estimated Primary Completion Date	November 1999
Eligibility Criteria	Inclusion Criteria: - Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season - Patient is a nonsmoker - Patient is in good general health Exclusion Criteria: - Patient is hospitalized - Patient is a woman who is less than 8 weeks postpartum or is breast-feeding - Patient intends to move or vacation away during the study - Patient has had any major surgery within 4 weeks of study start - Patient is a current or past abuser of alcohol or illicit drugs - Patient has been treated in an emergency room for asthma in the past month - Patient had an upper respiratory infection with in 3 weeks prior to study start - Patient has any active pulmonary disorder other than asthma
Gender	Both
Ages	15 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00963599
Other Study ID Numbers	0476A-117
Has Data Monitoring Committee	Not Provided
Information Provided By	Merck Sharp & Dohme Corp.
Study Sponsor	Merck Sharp & Dohme Corp.
Collaborators	Not Provided
Investigators	Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Verification Date	February 2014