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Completed

NCT Number: NCT00771160

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

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

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Key information

Conditions

Rhinitis, Allergic Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast sodium

Drug

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

Other names: Singulair

Primary outcomes

  1. Any clinical or laboratory adverse experience

    Time frame: 12 weeks

Secondary outcomes

  1. 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

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Oct 13, 2008
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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