Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
NCT ID:
NCT01637116
Eligibility Criteria:
Inclusion Criteria:
* chronic spontaneous urticaria
* disease duration \> 6 weeks
* signed and dated informed consent
* age 18 years or older
* Non sedating antihistamines may be used on an "on demand" basis throughout the study, in case of high urticaria activity \[\>50 wheals, and intense pruritus: urticaria activity score (UAS) of 6\] or in case of an emergency. Patients may take either cetirizine 10 mg up to a maximum of 4 tablets per 24 hours or fexofenadine 180 mg up to a maximum of 4 tablets per 24 hours. The use of antihistamines and the reason has to be documented by the patient in the patient diary. Patients should avoid the use of antihistamines during the study and especially during the three days prior to skin testing
* for female with childbearing potential: female will have to use a safe method of contraception to prevent pregnancy and will have to agree to continue this method of contraception during the whole study.
Exclusion Criteria:
* intake of immunosuppressives 3 month before Screening Visit and during the course of the study. Immunosuppressives including ciclosporin, methotrexate, mycophenolate, azathioprine and cyclophosphamide need to be stopped at least 3 month before Screening Visit
* intake of corticosteroids (e.g. oral, injection) 1 month before Screening Visit and during the course of the study. Corticosteroids need to be stopped at least 1 month before the Screening Visit.
* Previous or present treatment with anti-IgE-antibodies including omalizumab (Xolair)
* age below 18 years
* use of tricyclic antidepressants (e.g. amitriptyline), doxepin, leukotriene antagonists (e.g. montelukast, trade name: singulair), H2 antihistamines (e.g. cimetidine, famotidine, ranitidine), sulphasalazine, dapsone, tranexamic acid, warfarin, heparin during the last 4 weeks before the Screening Visit and during the course of the study.
* pregnancy, lactation or planned pregnancy during the study
* mentally incapacitated subjects
* patients protected by the law (adults under guardianship, or hospitalized in a public or private institution for a reason other than the study, or incarcerated)
* patients suffering from urticaria vasculitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01637116
Study Brief:
Protocol Section:
NCT01637116