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:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT00130234
Eligibility Criteria:
Inclusion Criteria:
* Males and non-pregnant, non-breastfeeding females
* Chronic urticaria defined as symptoms \>50% of the days or 3 days per week for more than 12 weeks
* History of angioedema
* Chronic daily therapy with anti-histamines and stable doses of antihistamines for at least 4 weeks.
* High baseline score for pruritis (at least 2 on a 3 point scale)
* No other etiology identified for chronic urticaria such as drug-related or physical urticaria as determined by history, physical examination and laboratory studies
Exclusion Criteria:
* Concomitant use of systemic corticosteroids for 1 month prior to enrollment. Topical steroid use will not be permitted, but inhaled topical steroids are allowed.
* Current use of immunosuppressive medication (cyclosporine, IVIg, methotrexate, cyclophosphamide). Any such medication will be discontinued for at least 6 weeks before screening.
* Treatment with any investigational agent within 30 days of screening
* Previous treatment with omalizumab
* Recent history of drug or alcohol abuse (within 3 years prior to study)
* Active atopic dermatitis requiring the use of topical steroid agents
* Clinically relevant cardiovascular, hepatic, neurologic, psychiatric, endocrine, or other major systemic disease making the protocol or interpretation of the study results difficult.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00130234
Study Brief:
Protocol Section:
NCT00130234