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Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974571
First Posted: September 10, 2009
Last Update Posted: July 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.

Condition Intervention Phase
Perennial Allergic Rhinitis Drug: montelukast sodium Drug: Comparator: cetirizine Drug: Comparator: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis

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 first 4 weeks of a 6-week treatment period ]

    Mean change from baseline in Daytime Nasal Symptoms score.

    Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.



Secondary Outcome Measures:
  • Mean Change From Baseline in Nighttime Symptoms Score [ Time Frame: Baseline and first 4 weeks in 6-week treatment period ]

    Mean change from baseline in Nighttime Symptoms Score.

    Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.


  • Mean Change From Baseline in Composite Symptoms Score [ Time Frame: Baseline and first 4 weeks in 6-week treatment period ]
    Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)].

  • Patient's Global Evaluation of Allergic Rhinitis [ Time Frame: End of the first 4 weeks in 6-week treatment period ]
    An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.

  • Physician's Global Evaluation of Allergic Rhinitis [ Time Frame: End of the first 4 weeks in 6-week treatment period ]
    An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.


Enrollment: 1365
Study Start Date: November 2001
Study Completion Date: May 2002
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
montelukast
Drug: montelukast sodium
montelukast 10 mg tablet orally once daily at bedtime for 6 weeks
Active Comparator: 2
cetirizine
Drug: Comparator: cetirizine
cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks
Placebo Comparator: 3
placebo
Drug: Comparator: placebo
placebo tablet orally once daily at bedtime for 6 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a documented clinical history of perennial allergic rhinitis
  • Patient is a nonsmoker
  • Patient is in good general health

Exclusion Criteria:

  • Patient is hospitalized
  • Patient is a woman who is <8 weeks postpartum or is breast-feeding
  • Patient is a current or past abuser of alcohol or illicit drugs
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974571


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: NCT00974571     History of Changes
Other Study ID Numbers: 0476-246
MK0476-246
2009_659
First Submitted: September 9, 2009
First Posted: September 10, 2009
Results First Submitted: September 17, 2009
Results First Posted: June 7, 2010
Last Update Posted: July 16, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Cetirizine
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents