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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00963599
Other study ID # 0476A-117
Secondary ID MK0476A-1172009_
Status Completed
Phase Phase 3
First received
Last updated
Start date September 1999
Est. completion date November 1999

Study information

Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 907
Est. completion date November 1999
Est. primary completion date November 1999
Accepts healthy volunteers No
Gender All
Age group 15 Years to 85 Years
Eligibility 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

Study Design


Intervention

Drug:
Comparator: montelukast/loratadine
montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks
Comparator: montelukast
montelukast 10 mg tablet taken once daily at bed time for 2 weeks
Comparator: loratadine
loratadine 10 mg tablet taken once daily at bed time for 2 weeks
Comparator: placebo
placebo tablet taken once daily at bed time for 2 weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Nayak AS, Philip G, Lu S, Malice MP, Reiss TF; Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-c — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change From Baseline in Daytime Nasal Symptoms Score 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. Baseline and Week 2
Secondary Mean Change From Baseline in Nighttime Symptoms Score 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. Baseline and Week 2
Secondary Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) 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)). Baseline and Week 2
Secondary Mean Change From Baseline in Daytime Eye Symptoms Score 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. Baseline and Week 2
Secondary Mean Change From Baseline in Daytime Nasal Congestion Score Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)). Baseline and Week 2
Secondary Mean Change From Baseline in Daytime Rhinorrhea Score Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)). Baseline and Week 2
Secondary Mean Change From Baseline in Daytime Nasal Itching Score Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)). Baseline and Week 2
Secondary Mean Change From Baseline in Daytime Sneezing Score Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). Baseline and Week 2
Secondary Mean Change From Baseline in Nasal Congestion Upon Awakening Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)). Baseline and Week 2
Secondary Patient's Global Evaluation of Allergic Rhinitis 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). Week 2
Secondary Physician's Global Evaluation of Allergic Rhinitis 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). Week 2
Secondary Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score 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. Week 2
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