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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT01617733
Eligibility Criteria:
Inclusion Criteria:
* To be verified at Visit one and confirmed at Visit two
* Male or female patients aged 18-80 years
* Signs and symptoms consistent with Nelson's Syndrome
* Biochemistry consistent with Nelsons syndrome: failure to suppress plasma ACTH to less than 200 pg/ml at 2 hours following morning dose of hydrocortisone
* Negative pregnancy test where applicable
Exclusion Criteria:
* Received any prior or current treatment with a pasireotide or other somatostatin analogue.
* Requires surgery for recent significant deterioration in visual fields or other neurological signs related to tumour mass.
* Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis, or persistent ALT, AST, alkaline phosphates 2X\> upper limit of normal, or total bilirubin 1.5X\> upper limit of normal.
* Patients with symptomatic cholelithiasis
* Abnormal clinical laboratory values considered by the Investigator to be clinically significant and which could affect the interpretation of the study results
* QTcF interval as measured by ECG \>480msecs
* Any current or prior medical condition that may, in the opinion of the Investigator, interfere with the conduct of the study or evaluation of the results.
* Female patients who are pregnant or lactating, or of childbearing potential and not practising a medically acceptable method of birth control. Medically acceptable methods include including the oral contraceptive pill, intrauterine devices, mechanical methods (e.g. vaginal diaphragm, vaginal sponge, or condom with permicidal jelly).
* History of alcohol or drug abuse in the sixmonth period prior to Visit 1, or who plan to take an investigational
* History of alcohol or drug abuse in the six month period prior to Visit 1, or who plan to take an investigational drug for another study during this study.
* History of noncompliance to medical regimes or who are considered potentially unreliable.
* Pituitary radiotherapy within the last 1 year prior to study entry.
* Unable to complete the entire study for any reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01617733
Study Brief:
Protocol Section:
NCT01617733