A Comparison of Aerius Continuous Treatment Versus Aerius PRN for Chronic Idiopathic Urticaria (Study P03147)

NCT ID: NCT00783354

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-01
• Study Completion Date: 2004-04-01

Brief Summary

This double-blind pilot study was conducted to establish the best way of using desloratadine treatment to protect quality of life of chronic idiopathic urticaria (CIU) patients, after an initial 4-weeks of daily treatment: prolonging systematic daily treatment or as needed (PRN; in the case of symptoms).

Conditions

Urticaria; Chronic Idiopathic Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Continuous Treatment

Group Type: ACTIVE_COMPARATOR

desloratadine

Intervention Type: DRUG

Patients received desloratadine 5 mg daily, given as one tablet in the evening, and were asked to take one tablet of "rescue medication" (Placebo) in case of symptoms for 2 months.

PRN regimen

Group Type: EXPERIMENTAL

desloratadine

Intervention Type: DRUG

Patients received Placebo daily, given as one tablet in the evening, and were asked to take one tablet of "rescue medication" (desloratadine 5 mg) in case of symptoms for 2 months.

Interventions

desloratadine

Patients received desloratadine 5 mg daily, given as one tablet in the evening, and were asked to take one tablet of "rescue medication" (Placebo) in case of symptoms for 2 months.

Intervention Type: DRUG

desloratadine

Patients received Placebo daily, given as one tablet in the evening, and were asked to take one tablet of "rescue medication" (desloratadine 5 mg) in case of symptoms for 2 months.

Intervention Type: DRUG

Other Intervention Names

Aerius; SCH 34117; Aerius; SCH 34117

Eligibility Criteria

Inclusion Criteria

• Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
• Subjects must be >= 18 years of age
• Women of childbearing potential must have a negative urine pregnancy test at Visit 1 (Day 1) and must be using an acceptable method of birth control during the study.
• Subjects must be in general good health; ie, they must be free of any clinically significant disease (other than CIU) that would interfere with study evaluations.
• Subjects must understand and be able to adhere to visit schedules, and agree to complete the questionnaires and a diary.
• Subjects must have at least a 6-week history of CIU (pruritus and hives) prior to Visit 1.

Exclusion Criteria

• Women who are pregnant or nursing.
• Subjects who used any investigational drug in the last 30 days prior to Visit 1
• Subjects with asthma requiring chronic use of inhaled or systemic corticosteroids.
• Subjects who have been treated with any investigational antibodies for asthma or allergic rhinitis in the 90 days prior to Baseline.
• Subjects who have been treated with intra-muscular or intra-articular corticosteroids in the 90 days prior to Baseline.
• Subjects with urticaria that is primarily due to physical urticaria or other known etiology, except dermographism.
• Subjects treated by immunosuppressive drugs.
• Subjects who have been hospitalized (including an emergency department visit) because of deterioration in their CIU within 3 months prior to Visit 1.
• Subjects with a history of hypersensitivity to desloratadine or any of its excipients.
• Subjects previously randomized into this study.
• Subjects who have any clinically significant metabolic, cardiovascular, immunological, neurological, hematological, gastrointestinal, cerebrovascular, or respiratory disease, or any other disorder which, in the judgment of the investigator, may interfere with the study evaluations or affect subject safety.
• Subjects with a history of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study.
• Subjects with a history of noncompliance with medications or treatment protocols.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Grob JJ, Auquier P, Dreyfus I, Ortonne JP. How to prescribe antihistamines for chronic idiopathic urticaria: desloratadine daily vs PRN and quality of life. Allergy. 2009 Apr;64(4):605-12. doi: 10.1111/j.1398-9995.2008.01913.x. Epub 2008 Dec 30.

Reference Type: RESULT

PMID: 19133920 (View on PubMed)

Other Identifiers

P03147

Identifier Type: -

Identifier Source: org_study_id