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The Effect of Oxytocin on the Gastric Emptying
Plain-language guide to NCT00776360: early phase 1 randomized trial of Oxytocin, delayed gastric emptying on glp-1 medicines, 12 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00776360
- Phase
- early phase 1
- Status
- completed
- Start
- 2008-12
- Completion (planned or actual)
- 2009-12
- Participants
- 12 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Postprocedural Delayed Gastric Emptying
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this early phase 1 trial, researchers set out to test Oxytocin for delayed gastric emptying on glp-1 medicines.
The investigators are going to examine whether oxytocin has a prokinetic effect on gastric emptying in patients suffering from gastro paresis.
Oxytocin infusion will be compared with sodium chloride infusion.
It had two arms (groups): oxytocin, gastric emptying (experimental) and oxytocin (placebo comparator).
Oxytocin is given to study the gastric emptying rate.
Sodium chloride is given to study gastric emptying rate.
The registry classes the interventions as drug.
More on the Plan
Oxytocin infusion will be compared with sodium chloride infusion.The gastric emptying is estimade by sitntigraphy during 70 minutes, and performed twicw.
Once with saline and once with oxytocin.
Who Took Part
Enrollment: 12 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: Gastroparesis in diabetics.
The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: treatment with other prokinetics, other severe organic or psychological diseases.
How the Study Was Run
Design: randomized, single-group and double-blind.
The delayed gastric emptying on glp-1 medicines participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.
Blinding on both sides kept the delayed gastric emptying on glp-1 medicines participants and researchers unaware of who received Oxytocin.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
Those kept unaware of assignments: participant and investigator.
It started in 2008-12 with completion listed for 2009-12.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a early phase 1, randomized trial of Oxytocin in 12 people with delayed gastric emptying on glp-1 medicines.
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 Oxytocin compound page, Delayed gastric emptying on GLP-1 medicines research.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
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.