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

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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