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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02427295
Other study ID # CSMS995BKR08T
Secondary ID
Status Recruiting
Phase Phase 4
First received February 4, 2015
Last updated April 22, 2015
Start date March 2014
Est. completion date December 2019

Study information

Verified date April 2015
Source Asan Medical Center
Contact minseon Kim, PhD
Phone 82-2-3010-3245
Email mskim@amc.seoul.kr
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial Summary

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


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 1
Est. completion date December 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (2)

Lead Sponsor Collaborator
Asan Medical Center Novartis Korea Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched) Change from within 3days post-operative in fasting serum IGF-1at 36 months post-operative No
Primary The time taken to IGF-1 normalization in each group. Change from within 3days post-operative in IGF-1 normalization at 36 months post-operative months post-operative No
Secondary GH suppressive responses (a nadir GH < 0.4 ng/ml) to oral glucose Change from Pre-operative in GH suppressive responses (a nadir GH < 0.4 ng/ml) at 36 months post-operative No
Secondary Clinical symptom and sign with AcroQoL questionnaire Change from Pre-operative in Clinical symptom and sign with AcroQoL questionnaire at 36 months post-operative No
Secondary Sleep quality and disturbance with written questionnaire Change from Pre-operative in Sleep quality and disturbance with written questionnaire at 24 months post-operative No
Secondary fasting glucose , postprandial glucose Change from pre-operative in fasting glucose , postprandial glucose at 36 months post-operative. No
Secondary insulin Change from pre-operative in insulin at 36 months post-operative. No
Secondary HbA1c change from pre-operative in HbA1c at 36 months post-operative. No
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