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

NCTNCT05929339Other idIRB00097699Other id1P01NS119159-01A1

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Overview

Status: Completed
Phase: Phase 2
Enrollment: 25 participants (actual)
Sponsor: Wake Forest University Health Sciences · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 17 Aug 2023
Primary completion: 2 Oct 2024
Completion: 2 Oct 2024
First posted: 3 Jul 2023
Last update posted: 28 Oct 2025
Conditions: Acute Pain · Chronic Pain · Healthy Volunteer

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph 2
Defining a PK and PD Model for Peripheral Analgesia After IV Oxytocin
NCT05929339
17 Aug 2023 to 2 Oct 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

OxytocinDrug

Arms3

Other
Verbal Pain Score at 10 Minutes
Two 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion. In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 10 minutes after starting the intervention, then every 15 minutes until 115 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion.
Other
Verbal Pain Score at 15 Minutes
Two 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion. In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 15 minutes after starting the intervention, then every 15 minutes until 120 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion.
Other
Verbal Pain Score at 20 Minutes
Two 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion. In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 20 minutes after starting the intervention, then every 15 minutes until 125 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion.

Primary outcomes1

Outcomes the sponsor listed as primary.

Verbal Pain Score at the End of 5 Minutes of Skin Heating
Time frame · 5-7 days
Registry description
Verbal pain score measured at one minute intervals during the 5 minute heating of the skin at intervals up to180 minutes after the initiation of the oxytocin infusions, then at 24 hours and 5-7 days after oxytocin infusions. The verbal pain score at the 5 minute measurement is the primary pharmacodynamic outcome for the purpose of modeling the pharmacokinetic-pharmacodynamic relationship. Note that the timing of the primary outcome differs among arms. Pain intensity report will be recorded each minute during the heating of the skin to 45 - 47 degrees Celsius . Pain will be determined using a Verbal Pain scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to THE WORST PAIN IMAGINABLE. Heating temperature will be determined according to pain rating during screening visit.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 5-7 days

Verbal Pain Score at the End of 5 Minutes of Skin Heating

Group	Value (score on a scale)	Spread
Verbal Pain Score at 10 Minutes	3.3	0.9
Verbal Pain Score at 15 Minutes	not posted	–
Verbal Pain Score at 20 Minutes	not posted	–

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Verbal Pain Score at 10 MinutesTwo 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion. In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 10 minutes after starting the intervention, then every 15 minutes until 115 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion. Oxytocin: Intravenous oxytocin	0 / 8	0 / 8	2 / 8
Verbal Pain Score at 15 MinutesTwo 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion. In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 15 minutes after starting the intervention, then every 15 minutes until 120 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion. Oxytocin: Intravenous oxytocin	0 / 8	0 / 8	4 / 8
Verbal Pain Score at 20 MinutesTwo 30 minute infusions of oxytocin, 10 IU, will be administered. The second infusion will be given 30 minutes after the completion of the first infusion. In this arm the first primary outcome measure (verbal pain report at the end of 5 minutes of skin heating) is obtained at 20 minutes after starting the intervention, then every 15 minutes until 125 minutes and at 180 minutes after starting the intervention. The primary outcome is also measured on separate study visits 24 hours and between 5-7 days after starting the first oxytocin infusion. Oxytocin: Intravenous oxytocin	0 / 9	0 / 9	5 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 75 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Male or female \> 18 and \< 75 years of age, Body Mass Index (BMI) \<40. 2. Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical status 1, 2, or 3. 3. For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication. For knee arthritis subjects, normal blood pressure or, for those with hypertension, pressure controlled with anti-hypertensives and with a resting heart rate 45-100 beats per minute. 4. Female subjects of child-bearing potential and those \< 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or cream), or total abstinence from heterosexual intercourse for a minimum of 1 full cycle before study drug administration. Exclusion Criteria: 1. Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin® 2. Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data 3. Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years 4. Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis. 5. Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval. 6. Subjects with past or current history of hyponatremia or at risk for hyponatremia; anyone taking thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, SSRI's, MAOI, or the recreational drug ecstasy. 7. Subjects with a known latex allergy. 8. Subjects with a pain score rating of 1 or less during the initial training session to a 5 minute heating of 45°C- 47 °Celsius to the lower calf.

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