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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)

NCT00751166 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2024-08-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-01
Primary Completion
2005-05-01
Completion
2005-05-01

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Entities

Drugs

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 NCT00751166 on ClinicalTrials.gov