NCT02427295

Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues

Long-term (up to 3 Years) Clinical and Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues: Open-labeled, Prospective, Parallel Group Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with treated surgery with or without long acting somatostatin analogues.

Detailed description

Patients who are diagnosed with acromegaly with a GH-secreting pituitary adenoma receiving TSA at the Asan Medical Center (Seoul, Korea) from Aug 2013 to Aug 2015 will be recruited. The eligible patient population will consist of 30 adult, male and female patient with Age 18 or older. * Number of patients by treatment group: Surgical treatment only = 15, Surgery with medical treatment = 15 * Number of Centers: 1 (single center)

Conditions

• Acromegaly

Interventions

Type	Name	Description
DRUG	Sandostatin (Octreotide Acetate)	For the patients outlined above (refer to 2), subjects who are not able to be treated by surgery alone: * Dose: Sandostatin LAR® 20mg per 4 weeks for 3 months -\> If serum IFG-1 levels fails to normalize, the dose of LAR will be increased to 30 mg. * Frequency: every 4 weeks. * Route of administration: IM injection.

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-12-01
• Completion: 2019-12-01
• First posted: 2015-04-28
• Last updated: 2015-04-28

Locations

1 site across 1 country: South Korea