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| Sponsor: | Schering-Plough |
|---|---|
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00536380 |
Purpose
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 |
|---|---|---|
|
Chronic Idiopathic Urticaria |
Drug: 5-mg Desloratadine Drug: 10-mg Desloratadine Drug: 20-mg Desloratadine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Study of the Efficacy, Safety, and Quality of Life (QOL) in Patients With Chronic Idiopathic Urticaria Dosed With AERIUS Tablets (Desloratadine 5 mg, 10 mg, or 20 mg Once Daily) |
| Enrollment: | 314 |
| Study Start Date: | September 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 5-mg Desloratadine
5-mg Desloratadine once daily
|
Drug: 5-mg Desloratadine
5-mg desloratadine tablets, once daily for four weeks.
Other Name: SCH 34117, Clarinex, Aerius
|
|
Experimental: 10-mg Desloratadine
10-mg Desloratadine once daily
|
Drug: 10-mg Desloratadine
10-mg desloratadine tablets, once daily for four weeks.
Other Name: SCH 34117, Clarinex, Aerius
|
|
Experimental: 20-mg Desloratadine
20-mg Desloratadine once daily
|
Drug: 20-mg Desloratadine
20-mg desloratadine tablets, once daily for four weeks.
Other Name: SCH 34117, Clarinex, Aerius
|
Eligibility| 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:
Contacts and Locations
More Information
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00536380 History of Changes |
| Other Study ID Numbers: | P04849 |
| Study First Received: | September 26, 2007 |
| Results First Received: | February 24, 2010 |
| Last Updated: | April 8, 2010 |
| Health Authority: | Germany: German Health Authority |
|
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 |