Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Desloratadine 5 mg; Placebo
Intervention description: Desloratadine 5 mg tablets; Placebo tablets
Intervention MeSH terms: Desloratadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 449.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This is an efficacy and safety study of desloratadine (MK-4117) in Japanese participants with
      seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that the change
      from Baseline in Total Nasal Symptom Score (TNSS) is improved by desloratadine compared to
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has at least a 2-year history of seasonal allergic rhinitis with typical symptoms

          -  Male or female who is unlikely to conceive: a surgically sterilized female, female who
             has reached natural menopause, or is of reproductive potential and agrees to either
             remain abstinent or use (or have her partner use) 2 acceptable methods of birth
             control from study start through 14 days after the last dose of study drug.

        Exclusion Criteria:

          -  Has a lower respiratory tract infection or has a nasopharyngolaryngeal infection
             (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute
             tonsillitis, etc.) requiring treatment

          -  Has a coexisting infection or systemic mycosis for which there are no effective
             antibiotics

          -  Has asthma that is under treatment and/or uncontrolled

          -  Has nasal septum ulcers, nasal surgery, or nasal trauma which have not healed

          -  Has vasomotor rhinitis or eosinophilic rhinitis

          -  Has a history of hypersensitivity to antihistamines or ingredients of study drug

          -  Has had treatment with corticosteroids (oral, injectable, suppository, depot drugs
             [injectable]) or immunological drugs within 28 days prior to Visit 2

          -  Is currently receiving treatment with another investigational drug or has received an
             investigational drug within prior 3 months

          -  Has started specific desensitization therapy (allergen immunotherapy) or nonspecific
             allassotherapy (Histaglobin, vaccine therapy, etc.) or who has received such therapies
             within prior 3 months

          -  Has received coagulation or resection using laser therapy etc. for treatment for nasal
             symptoms

          -  Will receive nasal nebulizer therapy and/or thermotherapy during study period

          -  Has severe hepatic, renal, cardiac, hematological disease, or other serious coexisting
             diseases and whose general condition is poor

          -  Has a history of malignancy or clinically important hematological disorder, except for
             adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix

          -  Has a history of severe drug allergy (e.g. anaphylactoid reaction)

          -  Is pregnant or lactating or may be pregnant

          -  Is planning a remote trip for more than 1 day during the Symptom Confirmation Period
             or for more than 2 days during the Treatment Period.