The study treatment period is 15 days in length and includes patients with pituitary Cushing’s disease who are candidates for surgical intervention as well as and patients who have recurrent Cushing’s post operatively.

Condition	Treatment or Intervention	Phase
Cushing's Syndrome	Drug: SOM230 s.c.	Phase II

Further Study Details: 

Expected Total Enrollment:  26

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients with pituitary Cushing’s disease within the two months prior to study entry
• Patients for whom written informed consent to participate in the study has been obtained
• Female patients of child bearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use barrier contraception throughout the course of the study, and for one month after the study has ended

Exclusion Criteria:

• Female patients who are pregnant or lactating
• Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study
• Poorly controlled diabetes mellitus as indicated by the presence of ketoacidosis or HgbA1C > 10
• Patients who have congestive heart failure, unstable angina, cardiac arrhythmia or history of acute MI less than one year prior to the study entry or clinically significant impairment in cardiovascular function (e.g. blood pressure of 190/100mmHg or greater)
• Patients with chronic liver disease
• Patients with clotting disorders or abnormal blood counts
• History of immuno-compromise, including a positive HIV test result
• Patients with active gall bladder disease
• Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
• Patients with active malignant disease (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)

Jesse Lee      862-778-2793    jesse.lee@pharma.novartis.com

California
      Cedars-Sinai Pituitary Center, Los Angeles,  California,  90048,  United States; Not yet recruiting
Massachusetts
      Massachusetts General Hospital NE Unit, Boston,  Massachusetts,  02114,  United States; Not yet recruiting
Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Not yet recruiting
France
      Service des Maladies, Paris,  75014,  France; Recruiting
Italy
      Clinical di Endocrinologia, Ancona,  Italy; Recruiting
United Kingdom
      Sir George E.Clark Metabolic Unit-Royal Victoria Hospital, Belfast,  United Kingdom; Recruiting

Study ID Numbers:  CSOM230B2208
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  July 30, 2004
ClinicalTrials.gov Identifier:  NCT00088608
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08