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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00795158 |
The purpose of this study was to determine the effect of desloratadine treatment on quality of life, daytime functioning, quality of sleep, symptoms, and disease severity in patients who had hives for 6 weeks or longer. Patients took desloratadine for 1 month. Once a week, patients filled out a questionnaire to tell how their hives affected their lives. This questionnaire is called the Dermatology Life Quality Index or DLQI. They also filled out a diary every day to tell how much itching they had, how many hives they had, and how their hives had affected their sleep or daily activities. The patients and doctors rated the patients' overall condition and how much relief patients got from treatment.
Condition | Intervention | Phase |
---|---|---|
Urticaria |
Drug: desloratadine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | An Open-Label Study of the Effects of Desloratadine Treatment on the Quality of Life of Patients With Chronic Urticaria |
Enrollment: | 282 |
Study Start Date: | November 2002 |
Study Completion Date: | January 2004 |
Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
Drug: desloratadine
desloratadine 5 mg tablets; one tablet orally once a day for 28 days
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P02988 |
Study First Received: | November 20, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00795158 |
Health Authority: | Italy: Ethics Committee |
Hypersensitivity Loratadine Skin Diseases Hypersensitivity, Immediate Histamine phosphate |
Quality of Life Urticaria Desloratadine Histamine |
Skin Diseases, Vascular Neurotransmitter Agents Immune System Diseases Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Histamine Agents Anti-Allergic Agents |
Cholinergic Agents Pharmacologic Actions Histamine Antagonists Therapeutic Uses Histamine H1 Antagonists Antipruritics Histamine H1 Antagonists, Non-Sedating Dermatologic Agents |