Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00979901
First received: September 17, 2009
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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 Effects of Montelukast in Patients With Seasonal Allergic Rhinitis--Spring 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 Over 2 Weeks [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    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. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. Scores were measured as 0 (best) to 3 (worst).


Secondary Outcome Measures:
  • Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst).

  • Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks [ Time Frame: Baseline and Week 2 ] [ Designated as safety issue: No ]
    Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst).

  • Patient's Global Evaluation of Allergic Rhinitis at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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. Scores were measured as 0 (best) to 6 (worst).

  • Physician's Global Evaluation of Allergic Rhinitis at Week 2 [ 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. Scores were measured as 0 (best) to 6 (worst).

  • Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst).


Enrollment: 1577
Study Start Date: March 2000
Study Completion Date: August 2000
Primary Completion Date: May 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
montelukast
Drug: Comparator: montelukast
10 mg montelukast tablet given once daily at bedtime for 2 weeks
Experimental: 2
loratadine
Drug: Comparator: loratadine
10 mg loratadine tablet given once daily at bedtime for 2 weeks
Placebo Comparator: 3
placebo
Drug: Comparator: placebo
placebo tablet given once daily at bedtime for 2 weeks
Experimental: 4
montelukast/loratadine
Drug: Comparator: montelukast/loratadine
montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime 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 history of seasonal allergic rhinitis symptoms that flare up during the study season
  • Patient is a nonsmoker and has been a nonsmoker for at least 1 year
  • 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
  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: NCT00979901

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00979901     History of Changes
Other Study ID Numbers: 0476A-162, MK0476A-162, 2009_664
Study First Received: September 17, 2009
Results First Received: September 23, 2009
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014