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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00724698
• Collaborator: (none)
• Enrollment: 3,011
• Duration (Months): 26

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rhinitis; Urticaria	Drug: Desloratadine

Study Design

• Study Type: Observational
• Actual Enrollment: 3011 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Desloratadine Tablet Among Filipino Patients
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adverse Events [Final Visit (Day 15)]

   Number of adverse events reported

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00724698
• Other Study ID Numbers: P04706
• First Posted: Jul 29, 2008
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Rhinitis; Urticaria; Desloratadine

Study Results

Participant Flow

Arm/Group Title	Desloratadine
Arm/Group Description	Desloratadine 5 mg daily
Period Title: Overall Study
STARTED	3011
COMPLETED	2921
NOT COMPLETED	90

Baseline Characteristics

Arm/Group Title	Desloratadine
Arm/Group Description	Desloratadine 5 mg daily
Overall Participants	3011
Age (Count of Participants)
<=18 years	239 7.9%
Between 18 and 65 years	2542 84.4%
>=65 years	230 7.6%
Sex: Female, Male (Count of Participants)
Female	1788 59.4%
Male	1223 40.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Desloratadine
Arm/Group Description	Desloratadine 5 mg daily
Measure Participants	3011
Mild	41
Moderate	15
Severe	1

Adverse Events

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PI agree only to use such information to conduct the study and will not be able to publish the results of any part of the study without previous writeen authorization from Schering-Plough.