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

What Was Tested

This registered phase 4 trial tested Octreotide.

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

It had three arms (groups): one (experimental), Group 3 : Rescue group (no intervention) and Gruop1 : Surgery only group (no intervention).

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 1 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could 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.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Octreotide group and the comparison group ran side by side rather than switching.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-03 with completion listed for 2018-12.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (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).

It also tracked 6 secondary outcomes, for example GH suppressive responses (a nadir GH < 0.4 ng/ml) to oral glucose, Clinical symptom and sign with AcroQoL questionnaire, Sleep quality and disturbance with written questionnaire, fasting glucose , postprandial glucose, insulin and HbA1c.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Octreotide in 1 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.