Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients
Acromegaly
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly, SOM230, Sandostatin
Eligibility Criteria
Inclusion Criteria: Patients with active acromegaly due to a pituitary adenoma Patients who have been previously treated for acromegaly with certain medications may be required to be without certain medications prior to entering the study Exclusion Criteria: Patients with compression of the optic chiasm causing any visual field defect Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression Patients who have received radiotherapy in the 2 years prior to the start of the trial Patients who have congestive heart failure, unstable angina, cardia arrhythmia, or a history of acute myocardial infarction within the three months preceding enrollment Patients with gallstone disease Patients with chronic liver disease Known hypersensitivity to Sandostatin or Sandostatin LAR Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control and highly effective method for birth control History of immunocompromise, including a positive HIV test result Patients who have a history of alcohol or drug abuse in the six-month period prior to the enrollment visit Patients who have participated in any clinical investigation with an investigational drug within 4 weeks prior to dosing
Sites / Locations
- Cedars Sinai Medical Center
- Massachusetts General Hospital
- University of Michigan Medical Center
- New York University/VA Medical Center
- University of Virginia Health System
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Sandostatin s.c. (Octreotide)
Pasireotide (SOM230)