Brief Title
Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues
Official Title
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
Brief 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)
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched)
Secondary Outcome
GH suppressive responses (a nadir GH < 0.4 ng/ml) to oral glucose
Condition
Acromegaly
Intervention
Sandostatin (Octreotide Acetate)
Study Arms / Comparison Groups
Group 2: Surgery + Medical treatment
Description: MRI : residual tumor 6 months post-op : IGF-1 >600 ng/ml medical treatment : Sandostatin (Octreotide Acetate)
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
1
Start Date
March 2014
Completion Date
December 2019
Primary Completion Date
December 2018
Eligibility Criteria
Inclusion Criteria:
1. Age 18 or older.
2. Patients diagnosed with acromegaly with GH-secreting pituitary adenoma on sellar MRI,
meeting the biochemical criteria outlined above (refer to 1. Diagnosis of acromegaly)
and with typical acromegalic features.
3. No prior use of somatostatin analogues.
4. Adequate hepatic and renal function
5. Provision of a signed written informed consent
Exclusion Criteria:
1. Severe co-morbid illness such as untreatable other malignancy and/or active
infections.
2. Pregnant or lactating women
3. Hypersensitivity to Sandostatin or any component of the formulation.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
minseon Kim, PhD, 82-2-3010-3245, [email protected]
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT02427295
Organization ID
CSMS995BKR08T
Responsible Party
Principal Investigator
Study Sponsor
Asan Medical Center
Collaborators
Novartis Korea Ltd.
Study Sponsor
minseon Kim, PhD, Principal Investigator, Asan Medical Center
Verification Date
April 2015