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A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Multicenter, Open Label Study to Assess the Safety and Efficacy of 600 µg SOM230, Administered Subcutaneously, b.i.d. in Patients With Cushing's Disease

NCT00088608•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 80 years

Sex

ALL

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)

Locations (5)

Cedars-Sinai Pituitary Center

Los Angeles, California, United States

Massachusetts General Hospital NE Unit

Boston, Massachusetts, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Midwest Endocrinology Associates

Milwaukee, Wisconsin, United States

Key Dates

Start Date

April 1, 2004

Primary Completion Date

June 1, 2006

Last Updated

November 7, 2016

Enrollment

ACTUAL participants

Conditions

Cushing's Syndrome

Interventions

SOM230 s.c.

DRUG

Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome

NCT05382156

Endogenous Cushing's Syndrome

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COMPLETED

Cardiovascular Status in Patients With Endogenous Cortisol Excess (Cushing's Syndrome)

NCT03880513

Endogenous Cushing's Syndrome

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COMPLETEDPHASE2

Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome

NCT02468193

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome

Cardiovascular Status in Patients With Endogenous Cortisol Excess (Cushing's Syndrome)

Study of Efficacy and Safety of Osilodrostat in Cushing's Syndrome

Biomarker Expression in Patients With ACTH-Dependent Cushing's Syndrome Before and After Surgery

Jugular Vein Sampling for Hormone Levels for the Diagnosis of Cushing Syndrome

A Study to Confirm Recurrent or Persistent Cushing's Syndrome in Patients With Signs or Symptoms of Hypercortisolemia