NCT05929339

Defining a PK and PD Model for Peripheral Analgesia After IV Oxytocin

Defining a Pharmacokinetic and Pharmacodynamic Model for Peripheral Analgesia After Intravenous Oxytocin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn about oxytocin ( a naturally occurring hormone made in the brain that transmits messages) and the effects it may have on thermal heat pain after intravenous administration. The main question it aims to define is the time course of change in pain score after a 5 minute heating of the skin administered at intervals during and following infusion of intravenous oxytocin in order to create a Pharmacokinetic and a Pharmacodynamic model for oxytocin-induced analgesia. Participants will be asked to rate thermal heat temperatures before, during and after the intravenous infusion of oxytocin.

Detailed description

The primary objective is to define the time course of change in pain score after a 5 minute heating of the skin applied at intervals during and following infusion of intravenous oxytocin in order to create a Pharmacokinetic and Pharmacodynamic model for oxytocin-induced analgesia.

Conditions

• Acute Pain
• Chronic Pain
• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Oxytocin	Intravenous oxytocin

Timeline

• Start date: 2023-08-17
• Primary completion: 2024-10-02
• Completion: 2024-10-02
• First posted: 2023-07-03
• Last updated: 2025-10-28
• Results posted: 2025-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study