Pharmacodynamics Of Product Octreotide Acetate Lar [amount hidden] Compared To Product Sandostatin LAR ®

What Was Tested

The trial (phase 1) is built around Octreotide.

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

Test.

The registry classes the interventions as drug.

Who Took Part

The registry lists 16 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 aged over 18, regardless of sex;.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: have participated in any experimental study or have ingested any drug trial within six months prior to the start of the study;; have been treated with somastostatina analog or dopamine agonist in the last 2 months;; present history of myocardial infarction, angina and / or heart failure;.

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.

In the crossover set-up each of the participants took both Octreotide and the comparison in turn, acting as their own control.

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

It started in 2010-03 with completion listed for 2010-05.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Quantification of serum levels of GH and IGF-I (time frame: Before drug administration, after drug administration, 1, 3, 7, 14, 21, 28, 35, 42, 49, 56 and 63 days after).

It also tracked 1 secondary outcome, for example Occurrence and severity of side effects during use of the product in order to ensure the security of it.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Octreotide in 16 people.

Its size is small, so on its own it can only give an early look.

Its status is suspended; no results are posted to the registry yet, so nothing here describes outcomes.

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