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
  Purpose

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 Intervention Phase
Urticaria
Chronic Idiopathic Urticaria
Drug: desloratadine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 129
Study Start Date: April 2003
Study Completion Date: April 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continuous Treatment 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
Experimental: PRN regimen 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00783354     History of Changes
Other Study ID Numbers: P03147
Study First Received: October 30, 2008
Last Updated: May 22, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Urticaria
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Vascular
Desloratadine
Cholinergic Agents
Cholinergic Antagonists
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014