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Clinical Trials/NCT00771160
NCT00771160CompletedPhase 3

MK0476 Phase III Long-term Study -Perennial Allergic Rhinitis-

Organon and Co0 sites120 target enrollmentStarted: September 2004Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
120
Primary Endpoint
Any clinical or laboratory adverse experience
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Experimental

MK0476 5mg

Intervention: montelukast sodium (Drug)

2

Experimental

MK0476 10mg

Intervention: montelukast sodium (Drug)

Outcomes

Primary Outcomes

Any clinical or laboratory adverse experience

Time Frame: 12 weeks

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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