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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00088608
First received: July 30, 2004
Last updated: November 29, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Cushing's Syndrome
Drug: SOM230 s.c.
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Urinary Free Cortisol after 15 days of treatment

Secondary Outcome Measures:
  • Serum cortisol
  • ACTH
  • Clinical manifestations
  • Pharmacokinetics
  • Safety
  • Tolerability
  • Development of biomarkers

Enrollment: 26
Study Start Date: April 2004
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088608

Locations
United States, California
Cedars-Sinai Pituitary Center
Los Angeles, California, United States, 90048
United States, Massachusetts
Massachusetts General Hospital NE Unit
Boston, Massachusetts, United States, 02114
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
Midwest Endocrinology Associates
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00088608     History of Changes
Other Study ID Numbers: CSOM230B2208
Study First Received: July 30, 2004
Last Updated: November 29, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cushing Syndrome
Pituitary ACTH Hypersecretion
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 31, 2014