Search / Trial NCT00001860

Sandostatin LAR Depot vs. Surgery for Treating Acromegaly

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Nov 3, 1999

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Trial Information

Current as of December 07, 2023

Completed

Keywords

Growth Hormone Somatostatin Insulin Like Growth Factor One Acromegaly Macroadenoma

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 e...

Gender

All

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.

Attachments

readout_NCT00001860_2023-12-07.pdf

4.5 MB

NCT00001860_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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