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NCT04431206 · ClinicalTrials.gov registry record · Phase 2

Generate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects

A Phase 2 study, sponsored by Wake Forest University Health Sciences.

Terminated
Registry status
Phase 2
Development phase
7
Enrollment target

NCT04431206 is a Phase 2 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 7 participants.

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The verdict

NCT04431206, a Phase 2 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.

TERMINATED
Registry status
Phase 2
Development phase
7 participants
Enrollment target

Study Summary

This is a study of participants that will receive an intravenous (IV) infusion of oxytocin (naturally occurring hormone that is made in the brain). In this study healthy volunteers and people with knee arthritis so severe that they may need joint replacement are recruited for a one day study. Each study participant will have an IV catheter placed. After placement of the IV catheter oxytocin will be given by IV infusion. Investigators will perform some tests to evaluate how oxytocin changes perceptions on the skin. Investigators will study a painful perception by placing a probe on the skin and heating it to 113 -117 degrees Fahrenheit (F) for 5 minutes. Each study participant will score any pain that is experienced on a 0 to 10 scale, and most people find that pain rises during the 5 minutes, but remains mild, usually around only 1 or 2 on the 0 to 10 scale. The 5 minute heating temperature will be determined according to the subjects pain rating during the screening visit. The main goal of the study is to determine the effect of oxytocin during and after a fixed rate intravenous infusion on reduction in pain to a sustained heat stimulus in order to generate a model for peripheral analgesia.

Interventions

  • DRUG Oxytocin

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2020-11-04
Est. Completion 2020-11-25
Phase Phase 2

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT04431206

The ClinicalTrials.gov registry entry for NCT04431206 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Oxytocin is the first listed.

NCT04431206 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04431206 about?

NCT04431206 is a clinical study titled "Generate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects". This is a study of participants that will receive an intravenous (IV) infusion of oxytocin (naturally occurring hormone that is made in the brain). In this study healthy volunteers and people with knee arthritis so severe that they may need joint replacement are recruited for a one day study. Each ...

What is the current status of trial NCT04431206?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2020-11-04. Estimated completion is 2020-11-25.

What interventions are being tested in trial NCT04431206?

The interventions under investigation include: Oxytocin (DRUG).

Who is sponsoring clinical trial NCT04431206?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.