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NCT00771160 Clinical Trial

MK0476 Study in Adult Patients With Perennial Allergic Rhinitis (0476-397)(COMPLETED)

Rhinitis, Allergic Clinical Trial

Official title:
MK0476 Phase III Long-term Study -Perennial Allergic Rhinitis-

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00771160
Other study ID # 0476-397
Secondary ID 2008_553
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2004
Est. completion date February 2005

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

Clinical Trial Summary

A clinical study evaluates the efficacy and safety of MK0476 in adult patients with Perennial Allergic rhinitis.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date February 2005
Est. primary completion date February 2005
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: - Adult Patients With Perennial Allergic Rhinitis Exclusion Criteria: - Patients Who Have Nasal Diseases (E.G., Nasal Polyp, Septonasal Arcuation, Hypertrophic Rhinitis), Upper Respiratory Infection, Sinusitis, Infectious Rhinitis And Those Disease Severe Enough To Interfere With Assessment Of Effectiveness - Patients Who Have Rhinitis Medicamentosa, Or Nonallergic Rhinitis (E.G., Vasomotor Rhinitis, Eosinophilia Rhinitis) - Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• montelukast sodium
Arm 1: montelukast tablet 5 mg, QD. Treatment period is 12-weeks. Arm 2: montelukast tablet 10 mg, QD. Treatment period is 12-weeks.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Any clinical or laboratory adverse experience 12 weeks
Secondary The daily mean of the composite nasal symptoms score at each of biweekly visits during the treatment period (average over the previous 2 weeks) or at time of termination 12 weeks
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