Phase II Study With ITF2984 in Acromegalic Patients

What Was Tested

The trial (phase 2) is built around Octreotide.

It had four arms (groups): Octreotide (active comparator), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

For patients who had previously received medical therapy for acromegaly a washout periods before study entry of 3 months for long-acting formulation of somatostatin analogs, 2 weeks for octreotide sc, 2 months for pegvisomant and/or cabergoline must be foreseen.

Each patient will be randomized and wll remain in the study for about 6 months, and they will attend a visit every two weeks.

The patients will be treated for 4 months in a total, in particular every month of treatment will be followed by a washout period of 2 weeks.

Patients will be randomized using a 4 way crossover design to receive ITF2984 or octreotide at each treatment month.

Who Took Part

The registry lists 48 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: Signed written informed consent. Patients aged between 18 to 80 years old inclusive.

The full record lists 5 inclusion and 21 exclusion criteria; among the exclusions: patients undergone pituitary surgery within the prior 6 months; patients who have received pituitary radiotherapy (within last 10 years); patients with additional active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix).

How the Study Was Run

The set-up was randomized, crossover and open-label.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2014-04 with completion listed for 2016-02.

It ran at 26 sites in Italy (7), Hungary (4), Poland (3), Romania (3), Czechia (2) and France (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: effect of treatment on GH and IGF-1 (time frame: 4 weeks).

It also tracked 6 secondary outcomes, for example signs and symptoms of acromegaly, PK profile of ITF2984 and Octreotide and effects of ITF2984 vs Octreotide on GH and IGF1 circulating levels.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 48 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, all human trials.