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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00783354
First received: October 30, 2008
Last updated: May 22, 2014
Last verified: May 2014

October 30, 2008
May 22, 2014
April 2003
February 2004   (final data collection date for primary outcome measure)
Changes from Visit 2 to Visit 4 of Vq-derm questionnaire score and DLQI quality of life score. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00783354 on ClinicalTrials.gov Archive Site
  • Estimation of disease free period after 3 months of daily treatment. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Average usage of rescue medication [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Change from Visit 2 in pruritus symptom score assessed by the patient. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • % of patients free of symptoms 2 months after Visit 4 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Changes from Visit 2 of overall conditions of CIU [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Discontinuation due to treatment failure [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Investigator's assessment of response to therapy [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Quality of disease control [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • Average consumption of treatment between Visit 2 and Visit 5 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Comparison of Aerius Continuous Treatment Versus Aerius PRN for Chronic Idiopathic Urticaria (Study P03147)
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

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Urticaria
  • Chronic Idiopathic Urticaria
  • Drug: 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.
    Other Names:
    • Aerius
    • SCH 34117
  • 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.
    Other Names:
    • Aerius
    • SCH 34117
  • Active Comparator: Continuous Treatment
    Intervention: Drug: desloratadine
  • Experimental: PRN regimen
    Intervention: Drug: desloratadine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
April 2004
February 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00783354
P03147
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP