- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03163875
Quality of Life in Patients With Chronic Urticaria
Quality of Life,Anxity,Depression and Quality of Sleep in Patients With Chronic Urticaria
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chronic urticaria signs and symptoms include: patches of red or white wheals, usually on the face, trunk, arms or legs. Wheals vary in size, change shape, and appear and fade repeatedly as the reaction runs its course. Itching is common, which may be severe. Swelling may occur that causes pain or burning (angioedema), especially inside the throat and around the eyes, cheeks, lips, hands, feet and genitals.
It is characterized by a tendency for signs and symptoms to flare with triggers such as heat, exercise and stress as well as a tendency for symptoms to recur frequently and unpredictably, sometimes for months or years The significance of chronic urticaria is sometimes trivialised because it is a non-life-threatening disease, but the condition can be very uncomfortable and interfere with sleep and daily activities. It is one of the most common and frustrating diseases for both patients and physicians Chronic urticaria has a major impact on quality of life (QoL) , with impact on activities of daily living. Chronic urticaria patients reportedly suffer considerable loss of energy, sleep disturbance and emotional upset as well as restrictions in the social life. Depression and anxiety are the most common psychiatric diagnoses. These psychiatric disorders could also influence QoL
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients with chronic urticaria defined as a 6-week or longer history of daily or almost daily itchy cutaneous weals with individual lesions lasting less than 24 h.
Age between 18 and 60 years.
Exclusion Criteria:
Patients who are unable to understand the questions, are unwilling to complete the questionnaire, or who have a psychiatric disorder, or obstructive sleep apnea.
Patients with malignant or central nervous system disease. Patients with cognitive impairment due to a current cerebral or psychotic illness.
Patients with current psychotherapy . glucocorticoids therapy in the last month.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
measure number of patients affected with depression and anxity
Time Frame: one year
|
The levels of depression and anxiety will be assessed by Hospital Anxiety Depression Scale (HADS) .
|
one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ziad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Chronic Urticaria
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Marcus MaurerCompletedNon-autoreactive Chronic Spontaneous Urticaria | Autoimmune Chronic Spontaneous Urticaria | Autoreactive, Non-autoimmune Chronic Spontaneous UrticariaGermany
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Novartis PharmaceuticalsRecruitingChronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)Germany, France, Spain, United States, Poland
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Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID)CompletedUrticaria ChronicUnited States
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United BioPharmaCompleted
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Novartis PharmaceuticalsCompletedCHRONIC SPONTANEOUS URTICARIAFrance
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University Hospital Inselspital, BerneNovartis; University of Bern; Adverse Drug Reactions, Advice and Consulting ADR-ACCompletedChronic Idiopathic Urticaria | Chronic Urticaria | Chronic Spontaneous UrticariaSwitzerland
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J. Uriach and CompanyTerminated
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United BioPharmaNot yet recruiting
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Celldex TherapeuticsRecruitingCold Urticaria | Symptomatic Dermographism | Chronic Inducible Urticaria | Cold-Induced UrticariaSpain, United States, Germany, South Africa, United Kingdom, Poland, Lithuania
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Enanta Pharmaceuticals, IncRecruitingChronic Spontaneous Urticaria | Chronic Inducible UrticariaUnited States
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University of NottinghamCompletedColorectal (Colon or Rectal) CancerUnited Kingdom
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