The Effect of Subcutaneous Infusions of 3 Doses of DG3173 on Growth Hormone Levels in Untreated Acromegalics

Plain-language guide to NCT02217800: phase 2 interventional trial of Octreotide, 8 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02217800
Phase: phase 2
Status: completed
Start: 2013-11
Completion (planned or actual): 2014-03
Participants: 8 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Acromegaly
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Octreotide.

It had 1 arm (groups): Saline, then DG3173, then octreotide (other).

The registry classes the interventions as drug.

Who Took Part

8 actual participants took part.

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: Men, women of non child-bearing potential, or women of child-bearing potential who either abstain from sexual intercourse, have a sterile partner or practice two medically approved, non-hormonal methods of contraception. Diagnosis of acromegaly of pituitary origin. Have given written informed consent. Ability to comply with the requirements of the protocol for the study.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: previous specific treatment for acromegaly in the 12 months prior to screening, including somatostatin analogues (ssas); surgery; radiotherapy and pegvisomant; treatment with dopamine agonists in the 3 months prior to screening; uncontrolled hypertension.

How the Study Was Run

It was run as a single-group and open-label study.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-11 with completion listed for 2014-03.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The Number of Patients Who Achieve a Trough Human Growth Hormone (hGH) Concentration of <[amount hidden]/L During the Last 12 Hours of the 23 Hour Profile Following Each Study Treatment.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 8 people.

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

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.

Our Notes on the Compound

Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.

Octreotide in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.