Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Octreotide; Pasireotide

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