Study Comparing SOM230 Subcutaneously and Sandostatin Subcutaneously in Acromegalic Patients

Plain-language guide to NCT00088582: phase 2 randomized trial of Octreotide and Pasireotide, 62 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00088582
Phase: phase 2
Status: completed
Start: 2004-03
Completion (planned or actual): 2005-10
Participants: 62 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Acromegaly
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 2 trial, researchers set out to test Octreotide and Pasireotide.

5 month study comparing SOM230 s.c. and Sandostatin s.c. in acromegalic patients.

It had two arms (groups): Sandostatin s.c. (Octreotide) (experimental) and Pasireotide (SOM230) (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 62 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Patients with active acromegaly due to a pituitary adenoma. Patients who have been previously treated for acromegaly with certain medications may be required to be without certain medications prior to entering the study.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: patients with compression of the optic chiasm causing any visual field defect; patients who have received radiotherapy in the 2 years prior to the start of the trial; patients who have congestive heart failure, unstable angina, cardia arrhythmia, or a history of acute myocardial infarction within the three months preceding enrollment.

How the Study Was Run

Design: randomized, crossover and open-label.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

Each person switched between Octreotide and the comparison at some point, usually with a gap in between.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2004-03 with completion listed for 2005-10.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Circulating GH- and IGF-1 concentrations measured every 2 weeks (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide and Pasireotide in 62 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compounds

Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.

Pasireotide: An FDA-approved multi-receptor somatostatin analog for Cushing's disease and acromegaly; high blood sugar is a common side effect.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.