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

November 3, 2016 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Pituitary Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital NE Unit
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Midwest Endocrinology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Urinary Free Cortisol after 15 days of treatment

Secondary Outcome Measures

Outcome Measure
Safety
Pharmacokinetics
Tolerability
Serum cortisol
ACTH
Clinical manifestations
Development of biomarkers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

July 30, 2004

First Submitted That Met QC Criteria

July 30, 2004

First Posted (Estimate)

August 2, 2004

Study Record Updates

Last Update Posted (Estimate)

November 6, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSOM230B2208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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