A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease - Full Text View

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 II

MedlinePlus related topics:

Cushing's Syndrome

Drug Information available for:

Pasireotide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

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

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

Estimated Enrollment:	26
Study Start Date:	April 2004

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

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

More Information

Study ID Numbers:	CSOM230B2208
First Received:	July 30, 2004
Last Updated:	August 6, 2007
ClinicalTrials.gov Identifier:	NCT00088608
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypothalamic Diseases

Pituitary ACTH Hypersecretion

Pituitary Diseases

Cushing Syndrome

Central Nervous System Diseases

Endocrine System Diseases

Adrenal Gland Diseases

Endocrinopathy

Brain Diseases

Adrenocortical Hyperfunction

Additional relevant MeSH terms:

Hyperpituitarism

Pathologic Processes

Disease

Syndrome

Nervous System Diseases

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00088608