Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues
NCT ID: NCT02427295
Last Updated: 2015-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1 participants
INTERVENTIONAL
2014-03-31
2019-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 2: Surgery + Medical treatment
MRI : residual tumor 6 months post-op : IGF-1 \>600 ng/ml
medical treatment : Sandostatin (Octreotide Acetate)
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.
Group 3 : Rescue group
If IGF-1 levels fails to normalize till post-op 18 months post-op, medical treatment will be added.)
No interventions assigned to this group
Gruop1 : Surgery only group
MRI : without residual tumor 6months post-operation
and IGF-1 \<600ng/ml
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Pregnant or lactating women
3. Hypersensitivity to Sandostatin or any component of the formulation.
18 Years
ALL
No
Sponsors
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Novartis Korea Ltd.
INDUSTRY
Asan Medical Center
OTHER
Responsible Party
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min seon kim
principal investigator
Principal Investigators
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minseon Kim, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSMS995BKR08T
Identifier Type: -
Identifier Source: org_study_id
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