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Validate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects

NCT04435704 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-09-19

No results posted yet for this study

Summary

The goal of this study is to validate the pharmacodynamic model for pain relief from oxytocin at a peripheral site by intravenous infusion targeted at different levels of the drug.

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 intravenous(IV) catheter placed. After placement of the IV catheter oxytocin will be given by IV infusion in varying amounts. The study team will perform some tests to evaluate how oxytocin changes perceptions on the skin. The study team will study a painful perception by placing a probe on the skin and heating it to 113 degrees Fahrenheit for 5 minutes. Each study participant will score any pain that is experienced on a 0 to 10 scale.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Oxytocin

Intravenous Oxytocin

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • James C Eisenach, MD · Wake Forest University Health Sciences

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04435704 on ClinicalTrials.gov