A Phase III, Multi-Center, Randomized, Parallel-Group, Placebo-Controlled and Double- Blind Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects With Perennial Allergic Rhinitis

4117-200

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.

2013-08-20

2014-01-26

2014-01-26

Completed

Early phase I

608

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).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 608, 'type': 'ACTUAL'}}

2024-05-17