A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)

• Status: Completed
• Trial end date: 2014-01-26
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with perennial allergic rhinitis. The primary hypothesis is that desloratadine is superior to placebo after 2 weeks of treatment with regard to change from baseline in Total Nasal Symptom Score among Japanese participants with perennial allergic rhinitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Desloratadine; Histamine; Histamine H1 Antagonists; Histamine H1 Antagonists, Non-Sedating; Loratadine

Criteria

Inclusion Criteria:

• Diagnosed with perennial allergic rhinitis

• Outpatient.

Exclusion Criteria:

• Lower respiratory tract infection or nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.)

• Coexisting infections or systemic mycosis for which there are no effective antibiotics

• Asthma complication under treatment

• Nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed

• Vasomotor rhinitis or eosinophilic rhinitis

• Nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug

• History of hypersensitivity to antihistamines or study drug

• Currently receiving treatment with another investigational drug or has received an investigational drug in the past 3 months

• Has started specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90 days (3 months) before the day of obtaining informed consent

• Severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor

• History of malignancy or clinically important hematological disorder

• History of severe drug allergy (e.g., anaphylactoid reaction).