Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly

What Was Tested

The trial (phase 3) is built around Octreotide.

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide.

It had four arms (groups): Run-in phase (experimental), RCT phase - Oral (experimental), RCT phase - Injectables (active comparator) and Combination phase (sub-study) (experimental).

Oral octreotide capsules.

Oral octreotide capsules.

Injectable somatostatin analogs (octreotide or lanreotide).

The registry classes the interventions as drug.

More on the Plan

The core study consisted of three phases: a Screening phase, Run-in phase and a Randomized Controlled Treatment (RCT) phase.

Eligible patients who were biochemically controlled on parenteral SRLs were switched to octreotide capsules for a 26-week period Run-in phase.

Patients whose acromegaly has been controlled biochemically on octreotide capsules at the end of the Run-in phase entered a 36-week open-label RCT phase, where they randomized to continue on octreotide capsules or switch back to their injectable SRL treatment (as received prior to Screening).

Following the completion of the core study (Screening, Run-in and RCT phases), eligible patients were offered to enter the Study Extension phase and receive octreotide capsules until product marketing or study termination.

Who Took Part

The registry lists 146 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Confirmed diagnosis of acromegaly. Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least 6 months. Biochemical control (IGF -1 \< 1.3 x ULN and GH \< 2.5ng/mL).

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: pituitary radiotherapy within 5 years; pituitary surgery within six months; patients who previously participated in ch-acm-01 study.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2016-02 with completion listed for 2020-10.

It ran at 53 sites in United States (18), Russia (9), Spain (5), United Kingdom (4), Hungary (3) and Italy (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Proportion of Patients Who Are Biochemically Controlled Throughout the RCT Phase (time frame: 62 weeks).

It also tracked 6 secondary outcomes, for example Proportion of Patients With Clinical and Biochemical Control at the End of the RCT Phase, Proportion of Patients of Those Completing the RCT Phase Who Entered the Study Extension Phase, Change in IGF-1 Levels in the RCT Phase and Change in GH Levels in the RCT Phase.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 146 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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