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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT03002233
Eligibility Criteria:
Inclusion Criteria:
* Adult non-smoking male and female subjects (≥ 18 years of age) who have ESRD requiring hemodialysis, at least 3 times a week.
* Subjects has a clinical diagnosis of UP, which is uncontrolled by current medications or treatments.(Part B only)
Exclusion Criteria:
* Subject has a known hypersensitivity to opioids or the ingredients of the study medication.
* Subject has pruritus other than related to ESRD (i.e., UP).(Part B only)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03002233
Study Brief:
Protocol Section:
NCT03002233