Safety and Biological Activity of C2L-OCT-01 PR in Acromegalic Patients

What Was Tested

The trial (phase 3) is built around Octreotide.

The purpose of this study is to assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in acromegalic patients.

It had two arms (groups): Population A (experimental) and Population B (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 40 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: Be greater than or equal to 18 years of age. Have a confirmed diagnosis of acromegaly based on the following criteria:. Typical clinical features and. Mean GH concentration \> 1.0 ng/mL following an oral glucose tolerance test (OGTT) and. Elevated serum IGF-1 levels above gender- and age- matched values.

The full record lists 11 inclusion and 15 exclusion criteria; among the exclusions: if female, be pregnant or lactating; have been treated with a gh receptor antagonist (pegvisomant) within the last 12 weeks; have used a dopamine agonist within the last 30 days.

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.

Being open-label, the Octreotide study did not mask who received what.

It started in 2008-02 with completion listed for 2009-08.

It ran at 10 sites in United States (5), Belarus (1), Hungary (1), Romania (1), Serbia (1) and Ukraine (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: To assess the safety profile of a new prolonged release formulation of octreotide acetate, C2L-OCT-01 PR, administered intra muscularly every 4, 5 or 6 weeks in acromegalic patients.

It also tracked 4 secondary outcomes, for example To assess the biologic and clinical activity of C2L-OCT-01 PR by examining the mean changes from baseline in GH and IGF-1 concentrations and To assess biological and clinical activity of C2L-OCT-01 PR by examining the pituitary tumor size.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Octreotide in 40 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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