AcromegalyPhase 4acromegalyNCT02427295
Hormonal Outcomes in Acromegalic Patients With Treated Surgery With or Without Long Acting Somatostatin Analogues
A Phase 4 study testing Sandostatin (Octreotide Acetate) in people with Acromegaly, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Sandostatin (Octreotide Acetate)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
minseon Kim, PhD, 82-2-3010-3245, mskim@amc.seoul.kr
About this study
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
Long-term (up to 3 years) clinical and hormonal outcomes in acromegalic patients with treated surgery with or without long acting somatostatin analogues.
Read the 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)
- Conditions
- Acromegaly
- Being tested
- Sandostatin (Octreotide Acetate)
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sandostatin (Octreotide Acetate)Drug
Also called Sandostatin LAR
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 2: Surgery + Medical treatment | Experimental | MRI : residual tumor 6 months post-op : IGF-1 >600 ng/ml
medical treatment : Sandostatin (Octreotide Acetate) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched)
Measured: 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.
Measured: 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
Measured: 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
Measured: Change from Pre-operative in Clinical symptom and sign with AcroQoL questionnaire at 36 months post-operative
Sleep quality and disturbance with written questionnaire
Measured: Change from Pre-operative in Sleep quality and disturbance with written questionnaire at 24 months post-operative
fasting glucose , postprandial glucose
Measured: Change from pre-operative in fasting glucose , postprandial glucose at 36 months post-operative.
insulin
Measured: Change from pre-operative in insulin at 36 months post-operative.
HbA1c
Measured: change from pre-operative in HbA1c at 36 months post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startMar 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Korea Ltd.
- Responsible party
- Principal investigator, min seon kim, Asan Medical Center
- Investigators
- minseon Kim, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427295
- Sponsor's protocol ID
- CSMS995BKR08T
- Acronym
- acromegaly
- Status last verified
- Apr 2015
- First submitted
- 4 Feb 2015
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02427295
- Acronym / sponsor ID
- acromegaly / CSMS995BKR08T
- Conditions
- Acromegaly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Novartis Korea Ltd.
- Study start
- Mar 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 2: Surgery + Medical treatment | Experimental | Drug: Sandostatin (Octreotide Acetate)MRI : residual tumor 6 months post-op : IGF-1 >600 ng/ml medical treatment : 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sandostatin (Octreotide Acetate)Also: Sandostatin LARFor 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. | Drug | Group 2: Surgery + Medical treatment |
Primary outcome
Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched)
Time frame: 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.
Time frame: Change from within 3days post-operative in IGF-1 normalization at 36 months post-operative months post-operative
6 secondary outcomes
GH suppressive responses (a nadir GH < 0.4 ng/ml) to oral glucose
Time frame: 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
Time frame: Change from Pre-operative in Clinical symptom and sign with AcroQoL questionnaire at 36 months post-operative
Sleep quality and disturbance with written questionnaire
Time frame: Change from Pre-operative in Sleep quality and disturbance with written questionnaire at 24 months post-operative
fasting glucose , postprandial glucose
Time frame: Change from pre-operative in fasting glucose , postprandial glucose at 36 months post-operative.
insulin
Time frame: Change from pre-operative in insulin at 36 months post-operative.
HbA1c
Time frame: change from pre-operative in HbA1c at 36 months post-operative.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
minseon Kim, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sandostatin (Octreotide Acetate) in people with Acromegaly, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact minseon Kim, PhD (82-2-3010-3245, mskim@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who achieved normalization of fasting serum IGF-1 (age and sex matched) (time frame: Change from within 3days post-operative in fasting serum IGF-1at 36 months post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015; AzTrials last refreshed its copy on 6 Nov 2026.