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

Date de début de l'étude : 1 mars 2004

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