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Effect of Octreotide on Saliva
Plain-language guide to NCT05340192: phase 1 interventional trial of Octreotide, 4 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05340192
- Phase
- phase 1
- Status
- completed
- Start
- 2019-09-24
- Completion (planned or actual)
- 2020-02-26
- Participants
- 4 (actual)
- Design
- na, open label (everyone knows who gets what), other
- Conditions studied
- Healthy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Octreotide.
The purpose of this study is to determine the effect of Octreotide on saliva enzymes.
It had 1 arm (groups): Healthy Volunteer (other).
The registry classes the interventions as drug.
More on the Plan
This is a healthy volunteer pilot study.
Who Took Part
4 actual participants took part.
It was open to people of any sex aged from 18 years up to 40 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Healthy adults between the ages of 18-40 years old. Healthy volunteer who is willing to undergo research activities. Healthy volunteer with no self-report of disease, oral symptoms or lesions, or cold or flu like symptoms that would affect the reflective measurements in the oral cavity. Ability to understand and the willingness to sign a written informed consent document.
The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: pregnant or nursing women; children under the age of 18 or adults over 40; complaint of oral symptoms (self-reported).
How the Study Was Run
The set-up was single-group and open-label.
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 2019-09-24 with completion listed for 2020-02-26.
It ran at 1 site in United States.
Its stated primary purpose is other.
What Was Measured
Primary outcome: To quantify the change of saliva proteomes of subjects pre-octreotide treatment (time frame: Day 1 pre-treatment). To quantify the change of saliva proteomes of subjects post-octreotide treatment (time frame: Day 1 post-treatment).
What This Means in Plain Language
Put simply, this is a phase 1 trial of Octreotide in 4 people.
Its size is small, so on its own it can only give an early look.
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.
Our Notes on the Compound
Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.
Related Pages
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.