A Study to Assess SOM230 in Patients With Pituitary Cushing's Disease
NCT ID: NCT00088608
Last Updated: 2016-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2004-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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SOM230 s.c.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Cedars-Sinai Pituitary Center
Los Angeles, California, United States
Massachusetts General Hospital NE Unit
Boston, Massachusetts, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Midwest Endocrinology Associates
Milwaukee, Wisconsin, United States
Countries
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References
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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. doi: 10.1210/jc.2008-1008. Epub 2008 Oct 28.
Trementino L, Cardinaletti M, Concettoni C, Marcelli G, Polenta B, Spinello M, Boscaro M, Arnaldi G. Salivary cortisol is a useful tool to assess the early response to pasireotide in patients with Cushing's disease. Pituitary. 2015 Feb;18(1):60-7. doi: 10.1007/s11102-014-0557-x.
Other Identifiers
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CSOM230B2208
Identifier Type: -
Identifier Source: org_study_id