Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:28 PM
Study NCT ID:
NCT04435704
Status:
WITHDRAWN
Last Update Posted:
2024-09-19
First Post:
2020-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Validate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was not initiated. No subjects enrolled.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
This is an unblinded Pharmacokinetic/Pharmacodynamic (PK/PD) study in which oxytocin is infused in increasing steps to different levels up and down in a set manner and the PD effect of pain relief from each level of oxytocin determined. 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.
In this study healthy people or those with knee arthritis so severe that they may need joint replacement are recruited for a one day study. 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. Oxytocin will be infused by IV route and 5-min heat pain tests obtained, but instead of giving oxytocin at a constant rate, the rate will be adjusted every 15 minutes to aim to get the right amount at the effect site to reduce pain by 10% of the maximum, then 30%, then 70%, then 90%, then back down to 70%, 30%, and 10%. At the end of each of these 7 15-min infusions participants will be tested for pain with heat and the study team will compare how effective the calculations for the effect site are to control the amount of pain relief obtained at each level.
This information will be analyzed by another group at Stanford University in the PK/PD Core part of this application. Mathematics will be used to calculate how quickly oxytocin moves from the blood to where it reduces pain (Part 1) and to test the accuracy of these calculations (Part 2).
In this study healthy people or those with knee arthritis so severe that they may need joint replacement are recruited for a one day study. 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. Oxytocin will be infused by IV route and 5-min heat pain tests obtained, but instead of giving oxytocin at a constant rate, the rate will be adjusted every 15 minutes to aim to get the right amount at the effect site to reduce pain by 10% of the maximum, then 30%, then 70%, then 90%, then back down to 70%, 30%, and 10%. At the end of each of these 7 15-min infusions participants will be tested for pain with heat and the study team will compare how effective the calculations for the effect site are to control the amount of pain relief obtained at each level.
This information will be analyzed by another group at Stanford University in the PK/PD Core part of this application. Mathematics will be used to calculate how quickly oxytocin moves from the blood to where it reduces pain (Part 1) and to test the accuracy of these calculations (Part 2).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: