MK0476 Study in Adult Patients With Allergic Rhinitis (0476-378)

Rhinitis Allergic Clinical Trial

Official title:

Mk0476 Phase II Dose Finding Study -Allergic Rhinitis-

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446186
• Other study ID #: 0476-378
• Secondary ID: 2007_009
• Status: Completed
• Phase: Phase 2
• Start date: February 2004
• Est. completion date: March 2004

Study information

• Verified date: January 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The clinical study evaluates the efficacy and safety of MK0476 in adult patients with allergic rhinitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 945
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• Adult patients with seasonal allergic rhinitis

Exclusion Criteria:

• Patients who have nasal diseases (e.g., nasal polyp, septonasal arcuation, hypertrophic rhinitis), upper respiratory infection, sinusitis, infectious rhinitis, ocular infection 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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis Allergic
• Rhinitis, Allergic

Intervention

Drug:
• MK0476, montelukast sodium / Duration of Treatment: 2 Weeks

• Comparator: placebo / Duration of Treatment: 2 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (2)

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

Okubo K, Baba K. Therapeutic effect of montelukast, a cysteinyl leukotriene receptor 1 antagonist, on Japanese patients with seasonal allergic rhinitis. Allergol Int. 2008 Sep;57(3):247-55. doi: 10.2332/allergolint.O-07-515. Epub 2008 Jul 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in the composite nasal symptoms score (average over the 2-week treatment period) in seasonal allergic rhinitis