A Comparison of Aerius Continuous Treatment Versus Aerius PRN for Chronic Idiopathic Urticaria (Study P03147)(COMPLETED) (ATTITUD)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00783354
First received: October 30, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
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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 Schering-Plough:
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:
|
| 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:
|
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 immunosuppresive 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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00783354 History of Changes |
| Other Study ID Numbers: | P03147 |
| Study First Received: | October 30, 2008 |
| Last Updated: | October 30, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Desloratadine Loratadine Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Antipruritics Dermatologic Agents Therapeutic Uses Anti-Allergic Agents |
ClinicalTrials.gov processed this record on May 23, 2013