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Sandostatin LAR vs. Surgery in Acromegalics With Macroadenoma

Phase 2
Not Enrolling
Acromegaly, Pituitary Neoplasm

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Trial Information

Sandostatin LAR vs. Surgery in Acromegalics With Macroadenoma

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.


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

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

August 1999

Completion Date:

July 2002

Related Keywords:

  • Acromegaly
  • Pituitary Neoplasm
  • Growth Hormone
  • Somatostatin
  • Insulin-like Growth Factor-One
  • Acromegaly
  • Macroadenoma
  • Acromegaly
  • Neoplasms
  • Pituitary Neoplasms



National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Bethesda, Maryland  20892