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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00960141
First received: August 14, 2009
Last updated: February 27, 2014
Last verified: February 2014

August 14, 2009
February 27, 2014
August 2000
October 2000   (final data collection date for primary outcome measure)
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 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.
Mean change from baseline in Daytime Nasal Symptoms Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00960141 on ClinicalTrials.gov Archive Site
  • 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 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.
  • 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 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.
  • Patient's Global Evaluation of Allergic Rhinitis [ Time Frame: Week 2 (or upon discontinuation) ] [ Designated as safety issue: No ]
    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).
  • 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: Baseline and Week 2 ] [ Designated as safety issue: No ]
    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.
  • Mean change from baseline in Nighttime Symptoms Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in Daytime Eye Symptoms score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Allergic Rhinitis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Physician's Global Evaluation of Allergic Rhinitis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in Rhinoconjunctivitis Quality-of-Life score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Fall Study

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
  • Drug: montelukast sodium
    montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks
  • Drug: Comparator: loratadine
    loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks
  • Drug: Comparator: placebo
    placebo tablet, taken orally once daily at bed time for 2 weeks
  • Experimental: 1
    montelukast
    Intervention: Drug: montelukast sodium
  • Active Comparator: 2
    loratadine
    Intervention: Drug: Comparator: loratadine
  • Placebo Comparator: 3
    placebo
    Intervention: Drug: Comparator: placebo
Chervinsky P, Philip G, Malice MP, Bardelas J, Nayak A, Marchal JL, van Adelsberg J, Bousquet J, Tozzi CA, Reiss TF. Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies. Ann Allergy Asthma Immunol. 2004 Mar;92(3):367-73.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
829
November 2000
October 2000   (final data collection date for primary outcome measure)

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
Both
15 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00960141
0476-192, MK0476-192, 2009_633
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP