Status:
COMPLETED
A Comparison of Aerius Continuous Treatment Versus Aerius PRN for Chronic Idiopathic Urticaria (Study P03147)
Lead Sponsor:
Organon and Co
Conditions:
Urticaria
Chronic Idiopathic Urticaria
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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-wee...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00783354
Start Date
April 1 2003
End Date
April 1 2004
Last Update
August 15 2024
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