Conditions: Seasonal Allergic Rhinitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 449
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) orally (PO) once daily (QD) in the morning for 2 weeks during the Treatment Period. arm 2: After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.

Interventions: intervention 1: Desloratadine 5 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Desloratadine 5 mg tablets intervention 2: Placebo tablets

Protocol document: