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An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

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ClinicalTrials.gov Identifier: NCT00127647
Recruitment Status : Completed
First Posted : August 8, 2005
Last Update Posted : March 21, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Drug: montelukast sodium Drug: Comparator: pranlukast Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis
Study Start Date : November 2004
Primary Completion Date : April 2005
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
montelukast sodium 5 mg, QD 2-weeks
Drug: montelukast sodium
montelukast sodium; 5 mg, 10 mg QD 2-weeks.
Other Names:
  • MK0476
  • Singulair
Experimental: 2
montelukast sodium 10 mg QD 2-weeks
Drug: montelukast sodium
montelukast sodium; 5 mg, 10 mg QD 2-weeks.
Other Names:
  • MK0476
  • Singulair
Active Comparator: 3
Pranlukast 225 mg BID 2-weeks
Drug: Comparator: pranlukast
Pranlukast 225 mg BID 2-weeks.

Primary Outcome Measures :
  1. Composite Nasal Symptom Score

Secondary Outcome Measures :
  1. Daytime nasal symptom score, Nighttime nasal symptom score

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Japanese males and females with a 2-year documented history of seasonal allergic rhinitis symptoms and positive allergy testing (cedar, alder and/or cypress)

Exclusion Criteria:

  • Patients with drug-induced rhinitis or non-allergic rhinitis, or patients who used anti-histamine drugs (within 2 weeks) before the start of the observation period

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): NCT00127647

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

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00127647     History of Changes
Other Study ID Numbers: 0476-327
First Posted: August 8, 2005    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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