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| Sponsored by: |
Novartis |
|---|---|
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
More Information
| Study ID Numbers: | CSOM230B2208 |
| Study First Received: | July 30, 2004 |
| Last Updated: | August 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00088608 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hypothalamic Diseases Pituitary ACTH Hypersecretion Pituitary Diseases Cushing Syndrome Central Nervous System Diseases |
Endocrine System Diseases Adrenal Gland Diseases Endocrinopathy Brain Diseases Adrenocortical Hyperfunction |
|
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 |