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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00536380 |
This study will investigate the effectiveness of desloratadine at doses higher (10 mg and 20 mg) than currently approved (5 mg) for the treatment of chronic idiopathic urticaria. Subjects with chronic urticaria who are currently taking a second generation antihistamine will be treated with desloratadine (5, 10, or 20 mg) for 28 days.
Condition | Intervention | Phase |
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Chronic Idiopathic Urticaria |
Drug: 5-mg Desloratadine Drug: 10-mg Desloratadine Drug: 20-mg Desloratadine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Study of the Efficacy, Safety, and Quality of Life (QOL) in Patients With Chronic Idiopathic Urticaria Dosed With AERIUS Tablets (5 mg, 10 mg, or 20 mg Once Daily) |
Estimated Enrollment: | 600 |
Study Start Date: | September 2007 |
Study Completion Date: | March 2009 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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5-mg Desloratadine: Experimental
5-mg Desloratadine once daily
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Drug: 5-mg Desloratadine
5-mg desloratadine tablets, once daily for four weeks.
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10-mg Desloratadine: Experimental
10-mg Desloratadine once daily
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Drug: 10-mg Desloratadine
10-mg desloratadine tablets, once daily for four weeks.
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20-mg Desloratadine: Experimental
20-mg Desloratadine once daily
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Drug: 20-mg Desloratadine
20-mg desloratadine tablets, once daily for four weeks.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who are postmenopausal for >1 year (i.e., women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study. Nonsterile or premenopausal female subjects must be using a medically accepted method of birth control, ie, double-barrier method (eg, male or female condom and spermicide), oral contraceptive, Depo-Provera, NuvaRing, contraceptive transdermal patch, etc, for female subjects of childbearing potential prior to screening and during the study.
Women of childbearing potential should be counseled in the appropriate use of birth control while in the study.
Vasectomy or tubal ligation is considered a single barrier. Women who are not currently sexually active must agree and consent to use one of the above-mentioned methods if they become sexually active while participating in the study.
Exclusion Criteria:
Have any of the following clinical conditions:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04849 |
Study First Received: | September 26, 2007 |
Last Updated: | May 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00536380 History of Changes |
Health Authority: | Germany: German Health Authority |
Neurotransmitter Agents Skin Diseases Cholinergic Antagonists Quality of Life Urticaria Anti-Allergic Agents Cholinergic Agents Desloratadine |
Histamine Hypersensitivity Histamine Antagonists Loratadine Hypersensitivity, Immediate Antipruritics Histamine H1 Antagonists Histamine phosphate |
Skin Diseases, Vascular Neurotransmitter Agents Skin Diseases Immune System Diseases Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Histamine Agents Urticaria Anti-Allergic Agents Cholinergic Agents |
Desloratadine Pharmacologic Actions Hypersensitivity Histamine Antagonists Loratadine Therapeutic Uses Hypersensitivity, Immediate Antipruritics Histamine H1 Antagonists Histamine H1 Antagonists, Non-Sedating Dermatologic Agents |