Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

A Multicenter, Randomized, Crossover, Open Label Dose Finding Study to Compare the Safety, Efficacy and PK/PD Relationship of Multiple Doses of SOM230 and Sandostatin in Acromegalic Patients

5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.

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