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Efficacy and Safety of Desloratadine vs. Fexofenadine 180 mg. vs. Placebo for Treating Seasonal Allergic Rhinitis (SAR)(Study P04053)(COMPLETED)

NCT00783211 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 722

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 (fexofenadine) and a placebo control to evaluate desloratadine 5 mg once daily during a 15-day treatment period. The active treatments and placebo were allocated in a 2:2:1 ratio.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

desloratadine

desloratadine, 5 mg oral tablets, once daily for 15 days

DRUG

fexofenadine

fexofenadine, 180 mg tablets, once daily for 15 days; for purposes of blinding, fexofenadine tablets were over encapsulated

DRUG

placebo

placebo, once daily for 15 days

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-01
Primary Completion
2004-10-01
Completion
2004-10-01

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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 NCT00783211 on ClinicalTrials.gov