A Comparison of Aerius Continuous Treatment Versus Aerius PRN for Chronic Idiopathic Urticaria (Study P03147) (ATTITUD)
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|ClinicalTrials.gov Identifier: NCT00783354|
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : March 29, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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).
|Condition or disease||Intervention/treatment||Phase|
|Urticaria Chronic Idiopathic Urticaria||Drug: desloratadine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Pilot, Multicenter, Double-blind Randomized Study for Comparison of Aerius® "Continuous Treatment" Versus Aerius® "PRN Regimen" on Chronic Idiopathic Urticaria Patient Quality of Life|
|Actual Study Start Date :||April 1, 2003|
|Actual Primary Completion Date :||February 1, 2004|
|Actual Study Completion Date :||April 1, 2004|
|Active Comparator: Continuous Treatment||
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.
|Experimental: PRN regimen||
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.
Primary Outcome Measures :
- Changes from Visit 2 to Visit 4 of Vq-derm questionnaire score and DLQI quality of life score. [ Time Frame: 2 months ]
Secondary Outcome Measures :
- Estimation of disease free period after 3 months of daily treatment. [ Time Frame: 2 months ]
- Average usage of rescue medication [ Time Frame: 2 months ]
- Change from Visit 2 in pruritus symptom score assessed by the patient. [ Time Frame: 2 months ]
- % of patients free of symptoms 2 months after Visit 4 [ Time Frame: 2 months ]
- Changes from Visit 2 of overall conditions of CIU [ Time Frame: 2 months ]
- Discontinuation due to treatment failure [ Time Frame: 2 months ]
- Investigator's assessment of response to therapy [ Time Frame: 2 months ]
- Quality of disease control [ Time Frame: 2 months ]
- Average consumption of treatment between Visit 2 and Visit 5 [ Time Frame: 4 months ]
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