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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127647
First Posted: August 8, 2005
Last Update Posted: March 21, 2017
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
The purpose of this trial is to evaluate the efficacy and safety of an investigational drug in adult patients with allergic rhinitis.

Condition Intervention Phase
Rhinitis, Allergic, Seasonal Drug: montelukast sodium Drug: Comparator: pranlukast Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Composite Nasal Symptom Score

Secondary Outcome Measures:
  • Daytime nasal symptom score, Nighttime nasal symptom score

Enrollment: 1375
Study Start Date: November 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
  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): NCT00127647


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

Publications:
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
MK0476-327
2005_038
First Submitted: August 4, 2005
First Posted: August 8, 2005
Last Update Posted: March 21, 2017
Last Verified: March 2017

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