NCT00751166

A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03736)

A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (CIU)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, double-blind, parallel-group, multicenter study that used both an active control (cetirizine) and a placebo control to evaluate desloratadine 5 mg once daily during a 28-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio.

Conditions

• Urticaria

Interventions

Type	Name	Description
DRUG	Desloratadine	Desloratadine 5 mg, oral tablet, once daily in the morning, 28 days
DRUG	Cetirizine	Cetirizine 10 mg, oral tablet (over encapsulated), once daily in the morning, 28 days
DRUG	placebo	placebo once daily for 28 days

Timeline

• Start date: 2004-03-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2008-09-11
• Last updated: 2024-08-15