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NCT00127647 Clinical Trial

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

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:
MK0476 Phase III Double-Blind Comparative Study - Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00127647
Other study ID # 0476-327
Secondary ID MK0476-3272005_0
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2004
Est. completion date April 2005

Study information
Verified date January 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 1375
Est. completion date April 2005
Est. primary completion date April 2005
Accepts healthy volunteers No
Gender All
Age group 15 Years to 64 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• montelukast sodium
montelukast sodium; 5 mg, 10 mg QD 2-weeks.
• Comparator: pranlukast
Pranlukast 225 mg BID 2-weeks.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Okubo K, Baba K. A double-blind non-inferiority clinical study of montelukast, a cysteinyl leukotriene receptor 1 antagonist, compared with pranlukast in patients with seasonal allergic rhinitis. Allergol Int. 2008 Dec;57(4):383-90. doi: 10.2332/allergoli — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Composite Nasal Symptom Score
Secondary Daytime nasal symptom score, Nighttime nasal symptom score
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