A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)

Organon and Co829 enrolled

Overview

A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

829

Conditions

Seasonal Allergic Rhinitis

Interventions

montelukast sodiumDRUG

montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks

Comparator: loratadineDRUG

loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks

Comparator: placeboDRUG

placebo tablet, taken orally once daily at bed time for 2 weeks

Eligibility

Sex: ALLMin age: 15 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season * Patient is a non-smoker * Patient is in good mental and physical health Exclusion Criteria: * Patient is hospitalized * Patient is a woman who is \<8 weeks postpartum or is breast feeding * Patient intends to move or vacation away during the study * Patient is a current or past abuser of alcohol or illicit drugs

Outcomes

Primary Outcomes

Mean Change From Baseline in Daytime Nasal Symptoms Score

Mean change from baseline in Daytime Nasal Symptoms score on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) was reported as the Daytime Nasal Symptoms Score.

Time frame: Baseline and Week 2

Secondary Outcomes

Mean Change From Baseline in Nighttime Symptoms Score

Mean change from baseline in Nighttime Symptoms Score on a 4-point scale \[0(best) to 3(worst)\]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score.

Time frame: Baseline and Week 2

Mean Change From Baseline in Daytime Eye Symptoms Score

Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale \[0(best) to 3(worst)\]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score.

Time frame: Baseline and Week 2

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, in answer to a single question regarding 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).

Time frame: Week 2 (or upon discontinuation)

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).

Data from ClinicalTrials.gov

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