A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease

Novartis

Status and phase

Completed

Phase 2

Conditions

Cushing's Syndrome

Treatments

Drug: SOM230 s.c.

Study type

Interventional

Funder types

Industry

Identifiers

NCT00088608

CSOM230B2208

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)