Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)

Launched by ORGANON AND CO · Dec 15, 2014

Keywords

ClinConnect Summary

This study consists of a one-week Symptom Confirmation Period during which participants undergo a single-blinded placebo run-in, a two-week double-blind Treatment Period and a two-week Follow-up Period.

Gender

ALL

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.