Evaluation of Desloratadine When Used in Patients With Either Allergic Rhinitis or Chronic Idiopathic Urticaria (Aerius)

February 7, 2022 updated by: Organon and Co

Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Tablet Among Filipino Patients

Eligible patients will be prescribed Desloratadine 1 tablet of 5 mg once daily. Patients will be asked to follow-up for a final visit after 14 days (Day 15) where the safety, tolerability and clinical efficacy will be measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3011

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Filipino patients diagnosed to have Allergic Rhinitis or Chronic Idiopathic Urticaria

Description

Inclusion Criteria:

  • Outpatient men or women, age 12 years and above.
  • Diagnosis of Allergic Rhinitis or Chronic Idiopathic Urticaria

Exclusion Criteria:

  • Known hypersensitivity to Desloratadine.
  • Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group
Patients diagnosed with Allergic Rhinitis or Chronic Idiopathic Urticaria
Desloratadine 5 mg once daily
Other Names:
  • SCH 034117

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Final Visit (Day 15)
Number of adverse events reported
Final Visit (Day 15)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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