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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT01963793
Eligibility Criteria:
Inclusion Criteria:
* Patient with Prurigo suffering from chronic pruritus
* Disease duration \> six month
* Therapy refractory to at least two previous antipruritic treatments with topical, intralesional or systemic corticosteroids, or other immunosuppressants, antihistamines, antipsychotics, antidepressants, anticonvulsants and/or UV-irradiation
* Adult male or female patients, aged 18 to 80 years
Exclusion Criteria:
* Concomitant medications that are primarily metabolized through Cytochrome P450 3A4
* Applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin less than 3 weeks prior to Visit 1 (Screening) or during the course of the trial
* UV-irradiation during the last 6 weeks prior to Visit 1 (Screening)
* Prescribed systemic medications are limited
* Clinically significant abnormalities in Blood analyses
* Anamnestic excessive use of alcohol or tobacco or drugs
* Presence of active tumor disease or history of malignancies within five years prior to Visit 1 (Screening)
* Known or suspected hypersensitivity to component(s) of investigational products
* Within the last 30 days or current participation in any other interventional clinical trial
* Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 6 month
* Previously enrolled/randomised in this clinical trial
* In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)
* Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial or are breast feeding
* Females of child-bearing potential with positive pregnancy test
* Subjects (or their partner) not using an adequate method of contraception (according to national requirements, as applicable)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01963793
Study Brief:
Protocol Section:
NCT01963793