NCT02320396

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 449 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Desloratadine 5 mg	Desloratadine 5 mg tablets
DRUG	Placebo	Placebo tablets

Timeline

• Start date: 2015-01-09
• Primary completion: 2015-04-27
• Completion: 2015-04-27
• First posted: 2014-12-19
• Last updated: 2024-05-17
• Results posted: 2016-05-30