Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001860
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Sandostatin LAR Depot vs Surgery for Treating Acromegaly
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Sandostatin LAR vs Surgery in Acromegalics With Macroadenoma
Status:
COMPLETED
Status Verified Date:
2002-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25 ngmL 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 25 ngmL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-DK-0162 | None | None | None |