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

NCT00536380 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2024-05-23

Study results available
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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

  • Chronic Idiopathic Urticaria

Interventions

DRUG

5-mg Desloratadine

5-mg desloratadine tablets, once daily for four weeks.

DRUG

10-mg Desloratadine

10-mg desloratadine tablets, once daily for four weeks.

DRUG

20-mg Desloratadine

20-mg desloratadine tablets, once daily for four weeks.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-04-30
Completion
2009-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536380 on ClinicalTrials.gov