Clinical Trials Directory

Trials / Completed

CompletedNCT00536380

Study for the Treatment of Chronic Idiopathic Urticaria With High Doses of AERIUS (Desloratadine) (Study P04849)

A Study of the Efficacy, Safety, and Quality of Life (QOL) in Patients With Chronic Idiopathic Urticaria Dosed With AERIUS Tablets (Desloratadine 5 mg, 10 mg, or 20 mg Once Daily)

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
314 (actual)
Sponsor
Organon and Co · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This study will investigate the effectiveness of desloratadine at doses higher (10 mg and 20 mg) than currently approved (5 mg) for the treatment of chronic idiopathic urticaria. Subjects with chronic urticaria who are currently taking a second generation antihistamine will be treated with desloratadine (5, 10, or 20 mg) for 28 days.

Conditions

Interventions

TypeNameDescription
DRUG5-mg Desloratadine5-mg desloratadine tablets, once daily for four weeks.
DRUG10-mg Desloratadine10-mg desloratadine tablets, once daily for four weeks.
DRUG20-mg Desloratadine20-mg desloratadine tablets, once daily for four weeks.

Timeline

Start date
2007-09-01
Primary completion
2009-04-01
Completion
2009-04-01
First posted
2007-09-27
Last updated
2024-05-23
Results posted
2010-05-03

Source: ClinicalTrials.gov record NCT00536380. Inclusion in this directory is not an endorsement.