Completed

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

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What is being tested

Data Collection

Who is being recruted

Adenoma+16

+ Adrenal Gland Diseases

+ Adrenocortical Hyperfunction

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA 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
Principal SponsorNovartis Pharmaceuticals
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenomaAdrenal Gland DiseasesAdrenocortical HyperfunctionBrain DiseasesCentral Nervous System DiseasesCushing SyndromeEndocrine System DiseasesEndocrine Gland NeoplasmsHyperpituitarismHypothalamic DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialNervous System DiseasesPituitary DiseasesPituitary NeoplasmsPituitary ACTH HypersecretionACTH-Secreting Pituitary Adenoma

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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

Cedars-Sinai Pituitary Center

Los Angeles, United StatesSee the location
Suspended

Massachusetts General Hospital NE Unit

Boston, United States
Suspended

Oregon Health & Science University

Portland, United States
Suspended

University of Pennsylvania

Philadelphia, United States
Completed5 Study Centers