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Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00974571
First received: September 9, 2009
Last updated: May 7, 2010
Last verified: May 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Merck:

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 ] [ Designated as safety issue: No ]
    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 ] [ 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 [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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: August 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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974571

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00974571     History of Changes
Other Study ID Numbers: 2009_659, MK0476-246
Study First Received: September 9, 2009
Results First Received: September 17, 2009
Last Updated: May 7, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013