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NCT03929367 · ClinicalTrials.gov registry record · Phase 4

PK Sampling After IV Oxytocin and Effects on Sensory Function in Healthy Volunteers

A Phase 4 study of Chronic Pain, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
Phase 4
Development phase
11
Enrollment target
1
Study location

NCT03929367 is a Phase 4 study of Chronic Pain that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 11 participants, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03929367, a Phase 4 study of Chronic Pain, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
Phase 4
Development phase
11 participants
Enrollment target
1
Study location

Study Summary

The primary goal of this protocol is to model change in oxytocin concentrations in plasma after intravenous (IV) administration. Additional measurements will be performed on sensory function that could be influenced by oxytocin during later time periods when blood samples are widely separated by time. This protocol will describe the pharmacokinetics (PK) of intravenous oxytocin in healthy adult men and adult,non-pregnant women. PK samples will be obtained after an injection of intravenous oxytocin 10 IU over 60 seconds. Blood will be drawn for the PK samples prior to the oxytocin administration and then 11 times after administration. There are two additional measures which will assess two different aspects of sensory function. MEASURE 1: Light Touch Frequency Threshold In order to determine the highest frequency that specific nerve fibers can respond to, a simple device that produces an oscillatory / vibratory stimulus will be used on the hand. The subject places fingertips, palm, and palm side of the wrist sequentially and the device is set to slowly decrease the frequency of vibration from 1 kHz until the subject first perceives this. This is repeated three times at each site and takes less than 5 minutes in total. This will be performed before the oxytocin administration and 6 times after the administration of IV Oxytocin. MEASURE 2: Sustained Heat The surface of the skin of the forearm or leg is heated to 113°F using a computer controlled thermode for a period of 5 minutes. This will be done before the IV Oxytocin and 4 times after the administration. A set of random thermal temperatures (98°F-122°F) will also be applied to the skin of the leg or forearm before the IV Oxytocin administration and 4 times after administration of IV Oxytocin.

Conditions Studied

Interventions

  • DRUG Oxytocin

Study Locations (1)

North Carolina

  • Wake Forest Baptist Medical Center - Winston-Salem

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2019-05-10
Est. Completion 2020-03-01
Phase Phase 4

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT03929367

The ClinicalTrials.gov registry entry for NCT03929367 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 301 other Chronic Pain trials with a reported enrollment target (99% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Pain appearing as the primary indexed condition, and to 1 intervention - of which Oxytocin is the first listed.

NCT03929367 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT03929367 about?

NCT03929367 is a clinical study titled "PK Sampling After IV Oxytocin and Effects on Sensory Function in Healthy Volunteers". The primary goal of this protocol is to model change in oxytocin concentrations in plasma after intravenous (IV) administration. Additional measurements will be performed on sensory function that could be influenced by oxytocin during later time periods when blood samples are widely separated by tim...

What is the current status of trial NCT03929367?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2019-05-10. Estimated completion is 2020-03-01.

What conditions does trial NCT03929367 study?

This clinical trial studies the following conditions: Chronic Pain.

What interventions are being tested in trial NCT03929367?

The interventions under investigation include: Oxytocin (DRUG).

Who is sponsoring clinical trial NCT03929367?

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

Where is trial NCT03929367 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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