Sandostatin LAR Depot vs. Surgery for Treating Acromegaly

Phase 2

Completed

• Conditions: Acromegaly; Pituitary Neoplasm

• Registration Number: NCT00001860
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 Timeline

• Study Start: 1999-08
• Study First Submitted: 1999-11-03
• Study First Submitted QC: 1999-11-03
• Study First Posted: 1999-11-04
• Status Verified: 2002-07
• Study Completion: 2002-07
• Last Update Submitted: 2008-03-03
• Last Update Posted: 2008-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); 🇺🇸 Bethesda, Maryland, United States