Back to resultsHormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues (acromegaly)
Primary Purpose
Acromegaly
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sandostatin (Octreotide Acetate)
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly
Eligibility Criteria
Inclusion Criteria:
- Age 18 or older.
- 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.
- No prior use of somatostatin analogues.
- Adequate hepatic and renal function
- Provision of a signed written informed consent
Exclusion Criteria:
- Severe co-morbid illness such as untreatable other malignancy and/or active infections.
- Pregnant or lactating women
- Hypersensitivity to Sandostatin or any component of the formulation.
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Group 2: Surgery + Medical treatment
Group 3 : Rescue group
Gruop1 : Surgery only group
Arm Description
MRI : residual tumor 6 months post-op : IGF-1 >600 ng/ml medical treatment : Sandostatin (Octreotide Acetate)
If IGF-1 levels fails to normalize till post-op 18 months post-op, medical treatment will be added.)
MRI : without residual tumor 6months post-operation and IGF-1 <600ng/ml
Outcomes
Primary Outcome Measures
Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched)
The time taken to IGF-1 normalization in each group.
Secondary Outcome Measures
GH suppressive responses (a nadir GH < 0.4 ng/ml) to oral glucose
Clinical symptom and sign with AcroQoL questionnaire
Sleep quality and disturbance with written questionnaire
fasting glucose , postprandial glucose
insulin
HbA1c
Full Information
NCT ID
NCT02427295
First Posted
February 4, 2015
Last Updated
April 22, 2015
Sponsor
Asan Medical Center
Collaborators
Novartis Korea Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02427295
Brief Title
Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues
Acronym
acromegaly
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Novartis Korea Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 2: Surgery + Medical treatment
Arm Type
Experimental
Arm Description
MRI : residual tumor 6 months post-op : IGF-1 >600 ng/ml
medical treatment : Sandostatin (Octreotide Acetate)
Arm Title
Group 3 : Rescue group
Arm Type
No Intervention
Arm Description
If IGF-1 levels fails to normalize till post-op 18 months post-op, medical treatment will be added.)
Arm Title
Gruop1 : Surgery only group
Arm Type
No Intervention
Arm Description
MRI : without residual tumor 6months post-operation
and IGF-1 <600ng/ml
Intervention Type
Drug
Intervention Name(s)
Sandostatin (Octreotide Acetate)
Other Intervention Name(s)
Sandostatin LAR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched)
Time Frame
Change from within 3days post-operative in fasting serum IGF-1at 36 months post-operative
Title
The time taken to IGF-1 normalization in each group.
Time Frame
Change from within 3days post-operative in IGF-1 normalization at 36 months post-operative months post-operative
Secondary Outcome Measure Information:
Title
GH suppressive responses (a nadir GH < 0.4 ng/ml) to oral glucose
Time Frame
Change from Pre-operative in GH suppressive responses (a nadir GH < 0.4 ng/ml) at 36 months post-operative
Title
Clinical symptom and sign with AcroQoL questionnaire
Time Frame
Change from Pre-operative in Clinical symptom and sign with AcroQoL questionnaire at 36 months post-operative
Title
Sleep quality and disturbance with written questionnaire
Time Frame
Change from Pre-operative in Sleep quality and disturbance with written questionnaire at 24 months post-operative
Title
fasting glucose , postprandial glucose
Time Frame
Change from pre-operative in fasting glucose , postprandial glucose at 36 months post-operative.
Title
insulin
Time Frame
Change from pre-operative in insulin at 36 months post-operative.
Title
HbA1c
Time Frame
change from pre-operative in HbA1c at 36 months post-operative.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 or older.
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.
No prior use of somatostatin analogues.
Adequate hepatic and renal function
Provision of a signed written informed consent
Exclusion Criteria:
Severe co-morbid illness such as untreatable other malignancy and/or active infections.
Pregnant or lactating women
Hypersensitivity to Sandostatin or any component of the formulation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
minseon Kim, PhD
Phone
82-2-3010-3245
Email
mskim@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
heesun Park, college
Phone
82-2-3010-4135
Email
guccienvy2@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
minseon Kim, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
minseon Kim, PhD
Phone
82-2-3010-3245
Email
mskim@amc.seoul.kr
12. IPD Sharing Statement
Learn more about this trial
Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues
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