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
  Purpose

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.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: montelukast sodium
Drug: Comparator: loratadine
Drug: Comparator: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Fall Study

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 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 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 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.


Enrollment: 829
Study Start Date: August 2000
Study Completion Date: November 2000
Primary Completion Date: October 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
montelukast
Drug: montelukast sodium
montelukast 10 mg tablet, taken orally once daily at bed time for 2 weeks
Active Comparator: 2
loratadine
Drug: Comparator: loratadine
loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks
Placebo Comparator: 3
placebo
Drug: Comparator: placebo
placebo tablet, taken orally once daily at bed time for 2 weeks

  Eligibility

Ages Eligible for Study:   15 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960141

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00960141     History of Changes
Other Study ID Numbers: 0476-192, MK0476-192, 2009_633
Study First Received: August 14, 2009
Results First Received: August 31, 2009
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Loratadine
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014