Sandostatin LAR Depot vs. Surgery for Treating Acromegaly
Sandostatin LAR Depot vs. Surgery for Treating Acromegaly
The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered
 Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with
 macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels.
 Secondary goals are to compare Sandostatin LAR® (Registered Trademark) Depot treatment and
 transsphenoidal surgery to achieve the following goals: suppress growth hormone levels to
 less than or equal to 2.5 ng/mL, relieve the clinical signs and symptoms of acromegaly,
 reduce the size of the macroadenomas, produce few side effects, assess the prognostic value
 of baseline pituitary adenoma size, extension and baseline growth hormone level on
 post-treatment growth hormone and IGF-1 levels, and assess the resource utilization of each
 treatment type.
The purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered
 Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with
 macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels.
 Secondary goals are to compare Sandostatin LAR® (Registered Trademark) Depot treatment and
 transsphenoidal surgery to achieve the following goals: suppress growth hormone levels to
 less than or equal to 2.5 ng/mL, relieve the clinical signs and symptoms of acromegaly,
 reduce the size of the macroadenomas, produce few side effects, assess the prognostic value
 of baseline pituitary adenoma size, extension and baseline growth hormone level on
 post-treatment growth hormone and IGF-1 levels, and assess the resource utilization of each
 treatment type.
INCLUSION CRITERIA:

 Male or female patients, 18 years of age or older.

 Newly diagnosed patients with acromegaly, or previously untreated.

 Presence of a pituitary tumor greater than 10 mm at greatest diameter (macroadenoma).

 Lack of suppression of GH to less than 2.0 ng/mL using a regular GH RIA, or less than one
 ng/mL using a two-site immunoradiometric or chemiluminescent GH assay, after oral
 administration of 100 g of glucose.

 IGF-1 levels above the upper limits of normal (adjusted for age and gender).

 Demonstrated tolerance to a test dose of s.c. Sandostatin Injection.

 Demonstrated responsiveness to a 100 ug s.c. Sandostatin Injection test dose, as evidenced
 by suppression of mean 4HR GH to less than 5 ng/mL, or to greater than 50 % of the baseline
 value.

 Patients who are able to provide written informed consent.

 EXCLUSION CRITERIA:

 Patients demonstrating intolerance to a s.c. Sandostatin (octreotide acetate) test dose.

 Patients who have received any prior treatment for their acromegaly, including
 radiotherapy, octreotide, bromocriptine, lanreotide, or prior surgery.

 Female patients who are pregnant or lactating, or are of childbearing potential and not
 practicing a medically acceptable method of birth control.

 Patients with compression of the optic chiasm significant enough to cause visual field
 defects on automated testing.

 Patients who require surgery for relief of any neurologic signs or symptoms associated with
 their tumor.

 Patients with symptomatic cholelithiasis.

 Patients who have congestive heart failure (NYHA Class III and IV), unstable angina,
 sustained ventricular tachycardia, ventricular fibrillation, or a history of acute
 myocardial infarction within the three months preceding study entry.

 Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic
 persistent hepatitis, or persistent ALT, AST, or alkaline phosphatase 2X greater than upper
 limit of normal; or direct bilirubin more than 10% greater than upper limit of normal.

 Patients with abnormal clinical laboratory values considered by the Investigator or the
 Sponsor's Medical Monitor to be clinically significant and which could affect the
 interpretation of the study results.

 Patients who have any current or prior medical condition that may interfere with the
 conduct of the study or of the evaluation of its result in the opinion of the Investigator
 or Sponsor's Medical Monitor.

 Patients who have a history of alcohol or drug abuse in the six month period prior to Visit
 1.

 Patients who have received any investigational drug within one month prior to Visit 1, or
 who plan to take an investigational drug during the study.

 Patients with any mental impairment limiting their ability to comply with all study
 requirements.

 Patients who, for any reason, will be unable to complete the entire study.