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Completed

NCT Number: NCT00960141

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

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.

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

15 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast sodium

Drug

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

Comparator: loratadine

Drug

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

Comparator: placebo

Drug

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

Primary outcomes

  1. Mean Change From Baseline in Daytime Nasal Symptoms Score

    Time frame: Baseline and Week 2

    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.

Secondary outcomes

  1. Mean Change From Baseline in Nighttime Symptoms Score

    Time frame: Baseline and Week 2

    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.

  2. Mean Change From Baseline in Daytime Eye Symptoms Score

    Time frame: Baseline and Week 2

    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.

  3. Patient's Global Evaluation of Allergic Rhinitis

    Time frame: Week 2 (or upon discontinuation)

    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).

  4. Physician's Global Evaluation of Allergic Rhinitis

    Time frame: Week 2

    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).

  5. Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score

    Time frame: Baseline and Week 2

    Patients completed a validated, self-administered questionnaire, which included 28 questions on a 7-point scale [score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Fall Study

Important dates

Study start
2000
Primary completion
2000
Study completion
2000
First posted
Aug 17, 2009
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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