Efficacy and Safety of C2L-OCT-01 PR in Acromegalic Patients

What Was Tested

The trial (phase 3) is built around Octreotide.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 65 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Subject must be diagnosed with active acromegaly. If subject is treated with a long acting somatostatin analogue, the treatment must have been unchanged for a period of at least 12 weeks prior to entry. If the subject is receiving a dopamine agonist, it must be stopped 14 days prior to receiving the study medication. The subject should be able to understand the instructions, provide a written consent and abide by the study restrictions.

The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: women of childbearing potential who are not taking adequate contraception or who are pregnant or lactating; subjects previously treated with a growth hormone receptor antagonist (pegvisomant) within 12 weeks of study entry; subjects who have undergone pituitary surgery within 6 months or radiotherapy within 2 years prior to admission into the study.

How the Study Was Run

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

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 2007-04 with completion listed for 2008-02.

It ran at 6 sites in Belarus (1), Hungary (1), Romania (1), Serbia (1), Slovakia (1) and Ukraine (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Compare the mean serum concentrations of insulin-like growth factor-1 (IGF-1) and growth hormone (GH) in patients treated with C2L-OCT-01 PR, [amount hidden] or Sandostatin LAR [amount hidden].

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Octreotide in 65 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.