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

NCT02427295 | Unknown Phase 4

• 1 other identifier: CSMS995BKR08T
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (6)

• 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

• Clinical symptom and sign with AcroQoL questionnaire

  Change from Pre-operative in Clinical symptom and sign with AcroQoL questionnaire at 36 months post-operative

• Sleep quality and disturbance with written questionnaire

  Change from Pre-operative in Sleep quality and disturbance with written questionnaire at 24 months post-operative

• fasting glucose , postprandial glucose

  Change from pre-operative in fasting glucose , postprandial glucose at 36 months post-operative.

• insulin

  Change from pre-operative in insulin at 36 months post-operative.

Study Arms (3)

Group 2: Surgery + Medical treatment

EXPERIMENTAL

MRI : residual tumor 6 months post-op : IGF-1 \>600 ng/ml medical treatment : Sandostatin (Octreotide Acetate)

Drug: Sandostatin (Octreotide Acetate)

Group 3 : Rescue group

NO INTERVENTION

If IGF-1 levels fails to normalize till post-op 18 months post-op, medical treatment will be added.)

Gruop1 : Surgery only group

NO INTERVENTION

MRI : without residual tumor 6months post-operation and IGF-1 \<600ng/ml

Interventions

Sandostatin (Octreotide Acetate) DRUG

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.

Also known as: Sandostatin LAR

Group 2: Surgery + Medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead
• Novartis Korea Ltd.: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

MeSH Terms

Conditions

Acromegaly

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• minseon Kim, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

minseon Kim, PhD

CONTACT

82-2-3010-3245; mskim@amc.seoul.kr

heesun Park, college

CONTACT

82-2-3010-4135; guccienvy2@naver.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: April 28, 2015
• Study Start: March 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

KR (1)