Brief Title
Sandostatin LAR Depot vs. Surgery for Treating Acromegaly
Official Title
Sandostatin LAR vs. Surgery in Acromegalics With Macroadenoma
Brief Summary
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.
Detailed Description
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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Acromegaly
Intervention
Sandostatin LAR Depot versus transsphenoidal surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
5
Start Date
August 1999
Completion Date
July 2002
Eligibility Criteria
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.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00001860
Organization ID
990162
Secondary IDs
99-DK-0162
Study Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Sponsor
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Verification Date
July 2002