Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

Novartis

Status and phase

Completed

Phase 2

Conditions

Acromegaly

Treatments

Drug: Pasireotide (SOM230), Octreotide (Sandostatin)

Study type

Interventional

Funder types

Industry

Identifiers

CSOM230B2201

Details and patient eligibility

About

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

Enrollment

62 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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