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Validate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects

Plain-language guide to NCT04435704: phase 2 interventional trial of Oxytocin. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04435704
Phase
phase 2
Status
withdrawn
Start
2025-01
Completion (planned or actual)
2027-01
Participants
n/a (actual)
Design
na, open label (everyone knows who gets what), basic_science
Conditions studied
Osteoarthritis, Knee
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Oxytocin.

Each study participant will have an intravenous(IV) catheter placed.

It had 1 arm (groups): Oxytocin (experimental).

The registry classes the interventions as drug.

More on the Plan

All study participants will receive the same treatment and will not be blinded to the experimental plan, although particpants will not be informed when oxytocin levels are changing.

Participants will come to the Clinical Research Unit (CRU) and one intravenous catheter (IV) will be inserted in the forearm for oxytocin infusion.

In this study, the oxytocin rate will be changed every 15 minutes for 7 times.

Who Took Part

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male or female \> 18 and \< 75 years of age, Body Mass Index (BMI) \<40.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2025-01 with completion listed for 2027-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Verbal pain after heating the skin to 45 degrees Celsius (time frame: Baseline at time of infusion). Verbal pain after heating the skin to 45 degrees Celsius (time frame: 9 minutes after baseline). Verbal pain after heating the skin to 45 degrees Celsius (time frame: 24 minutes after baseline).

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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

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.