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

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00088608

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

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

Resource links provided by NLM:

MedlinePlus related topics: Cushing's Syndrome

Drug Information available for: Pasireotide

U.S. FDA Resources

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
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

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

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Boscaro M, Ludlam WH, Atkinson B, Glusman JE, Petersenn S, Reincke M, Snyder P, Tabarin A, Biller BM, Findling J, Melmed S, Darby CH, Hu K, Wang Y, Freda PU, Grossman AB, Frohman LA, Bertherat J. Treatment of pituitary-dependent Cushing's disease with the multireceptor ligand somatostatin analog pasireotide (SOM230): a multicenter, phase II trial. J Clin Endocrinol Metab. 2009 Jan;94(1):115-22. Epub 2008 Oct 28.

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CSOM230B2208
Study First Received:	July 30, 2004
Last Updated:	November 18, 2009
ClinicalTrials.gov Identifier:	NCT00088608 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypothalamic Diseases
Disease
Pituitary Diseases
Nervous System Diseases
Cushing Syndrome
Adrenal Gland Diseases
Endocrine System Diseases

Central Nervous System Diseases
Brain Diseases
Adrenocortical Hyperfunction
Pituitary ACTH Hypersecretion
Pathologic Processes
Hyperpituitarism
Syndrome

ClinicalTrials.gov processed this record on November 27, 2009