Text Size

An Approved Drug to Study a New Indication for Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00127647
First received: August 4, 2005
Last updated: September 17, 2008
Last verified: September 2008
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Composite Nasal Symptom Score

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

Enrollment: 1375
Study Start Date: November 2001
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

Ages Eligible for Study:   15 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127647

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00127647     History of Changes
Other Study ID Numbers: 2005_038, MK0476-327
Study First Received: August 4, 2005
Last Updated: September 17, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
 Pranlukast
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013