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

Acromegaly Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02427295
• Other study ID #: CSMS995BKR08T
• 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

• Acromegaly

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