- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00795522
An Open-Label Study of the Effects of Desloratadine (Aerius.) Treatment on the Quality of Life of Patients With Chronic Idiopathic Urticaria (Study P02540)
February 7, 2022 updated by: Organon and Co
An Open-Label Study of the Effects of Desloratadine (Aerius.) Treatment on the Quality of Life of Patients With Chronic Idiopathic Urticaria
This open-label study is being conducted to determine the effect of DL treatment for CIU on symptom and disease severity, quality of life, daytime functioning, and quality of sleep.
Study Overview
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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, of either sex and any race.
- Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation). Women of childbearing potential should be counseled in the appropriate use of birth control while in this study. Women who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.
- Subjects must be in general good health; i.e., 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 the dosing and visit schedules, and agree to complete the questionnaires and to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.
- Subjects must have at least a 6-week history of CIU (pruritus and hives) prior to Visit 1 (Screening).
- Subjects must have a pruritus score >= 2 and a hive score >= 1 at Visit 1.
- Subjects must be experiencing a current CIU flare of at least 3 weeks duration, with hives present at least 3 days per week, prior to Visit 1 (Screening).
- Subjects must score the overall condition of CIU >= 2 at both Visit 1 (Screening) and Visit 2 (Baseline).
- Subjects must have a total pruritus score of >= 14 for the sum of morning and evening (reflective) diary scores for the 3 days prior to Visit 2 (Baseline) plus the morning score on the day of Visit 2.
- Women of childbearing potential must have a negative urine pregnancy test at Visit 2 (Baseline).
Exclusion Criteria:
- Women who are pregnant or nursing.
- Subjects who have not observed the designated washout periods for any of the prohibited medications outlined.
- Subjects with asthma requiring chronic use of inhaled or systemic corticosteroids.
- Subjects with drug or food allergies that manifest as skin reactions.
- Subjects with urticaria that is primarily due to physical urticaria or other known etiology.
- Subjects with CIU unresponsive to antihistamines.
- Subjects who have been hospitalized (including an emergency department visit) because of deterioration in their CIU within 3 months prior to Visit 1 (Screening).
- Subjects with a history of hypersensitivity to desloratadine or any of its excipients.
- Subjects previously randomized into this study.
- Subjects who are staff personnel directly involved with the administration of this study.
- Subjects who have any clinically significant metabolic, cardiovascular, immunologic, neurologic, hematologic, 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Desloratadine
|
Subjects will receive DL 5 mg daily for 28 days.
Each active DL tablet contains 5 mg of desloratadine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in the Short Form 12 (SF-12) Health Survey Questionnaire, mental, physical and total scores on treatment days 7, 14, 21, and 28.
Time Frame: treatment days 7, 14, 21, and 28
|
treatment days 7, 14, 21, and 28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from Baseline in work/school attendance and self-assessed productivity as measured by the WPAI questionnaire
Time Frame: treatment days 7, 14, 21, and 28
|
treatment days 7, 14, 21, and 28
|
Change from Baseline in pruritus, the number of hives and the maximum size of hives, sleep quality, and activity impairment
Time Frame: treatment weeks 1, 2, 3, and 4
|
treatment weeks 1, 2, 3, and 4
|
The percent of subjects who rate their response to therapy as either Complete, Marked, or Moderate Relief
Time Frame: day 28
|
day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Primary Completion (Actual)
February 1, 2005
Study Completion (Actual)
March 1, 2005
Study Registration Dates
First Submitted
November 19, 2008
First Submitted That Met QC Criteria
November 20, 2008
First Posted (Estimate)
November 21, 2008
Study Record Updates
Last Update Posted (Actual)
February 17, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Skin Diseases, Vascular
- Hypersensitivity
- Urticaria
- Chronic Urticaria
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Antagonists
- Cholinergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Desloratadine
Other Study ID Numbers
- P02540
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urticaria
-
Marcus MaurerCompletedNon-autoreactive Chronic Spontaneous Urticaria | Autoimmune Chronic Spontaneous Urticaria | Autoreactive, Non-autoimmune Chronic Spontaneous UrticariaGermany
-
J. Uriach and CompanyTerminated
-
Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID)CompletedUrticaria ChronicUnited States
-
United BioPharmaCompleted
-
Novartis PharmaceuticalsCompletedCHRONIC SPONTANEOUS URTICARIAFrance
-
University Hospital Inselspital, BerneNovartis; University of Bern; Adverse Drug Reactions, Advice and Consulting ADR-ACCompletedChronic Idiopathic Urticaria | Chronic Urticaria | Chronic Spontaneous UrticariaSwitzerland
-
University Hospital, LilleRecruitingSpontaneous Urticaria, ChronicFrance
-
United BioPharmaNot yet recruiting
-
United BioPharmaRecruiting
-
Second Xiangya Hospital of Central South UniversityNot yet recruitingChronic Spontaneous UrticariaChina
Clinical Trials on Desloratadine
-
Organon and CoCompletedChronic Idiopathic Urticaria
-
Organon and CoCompleted
-
Organon and CoCompletedDermatitis | Eczema | Dermal Pruritus
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Organon and CoCompleted
-
Organon and CoCompleted
-
Sun Yat-sen UniversityCompletedNon-small Cell Lung CancerChina
-
Organon and CoCompletedRhinitis, Allergic, Seasonal
-
Organon and CoCompletedChronic Idiopathic Urticaria | Atopy
-
Organon and CoCompleted