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

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ClinicalTrials.gov Identifier: NCT00974571
Recruitment Status : Completed
First Posted : September 10, 2009
Results First Posted : June 7, 2010
Last Update Posted : July 16, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Perennial Allergic Rhinitis Drug: montelukast sodium Drug: Comparator: cetirizine Drug: Comparator: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1365 participants
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
Study Start Date : November 2001
Actual Primary Completion Date : May 2002
Actual Study Completion Date : May 2002

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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.


  2. 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)].

  3. 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.

  4. 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.



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Ages Eligible for Study:   15 Years to 85 Years   (Child, Adult, Older Adult)
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

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.

Additional Information:
Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00974571     History of Changes
Other Study ID Numbers: 0476-246
MK0476-246
2009_659
First Posted: September 10, 2009    Key Record Dates
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