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 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
NCT ID:
NCT01374906
Eligibility Criteria:
Inclusion Criteria:
* Karnofsky performance status ≥ 60 (i.e. requires occasional assistance, but is able to care for most of their personal needs)
* For patients on medical treatment for Cushing's disease the following washout periods must be completed before screening assessments are performed
* Inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week
* Pituitary directed agents: Dopamine agonists (bromocriptine, cabergoline) and PPARγ agonists (rosiglitazone or pioglitazone): 4 weeks
* Octreotide LAR, Lanreotide SR and Lanreotide autogel: 14 weeks
* Octreotide (immediate release formulation): 1 week
Exclusion Criteria:
* Patients who are considered candidates for surgical treatment at the time of study entry
* Patients who have received pituitary irradiation within the last ten years prior to visit 1
* Patients who have had any previous pasireotide treatment
* Patients who have been treated with mitotane during the last 6 months prior to Visit 1
* Diabetic patients on antihyperglycemic medications with poor glycemic control as evidenced by HbA1c \>8%
* Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF \>470 ms, hypokalemia, uncontrolled hypothyroidism, family history of long QT syndrome, or concomitant medications known to prolong QT interval
* Female patients who are pregnant or lactating, or are of childbearing potential (defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control. Sexually active males must use a condom during intercourse while taking the drug and for 2 months after the last dose of study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01374906
Study Brief:
Protocol Section:
NCT01374906