Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Generate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects

NCTNCT04431206Other idIRB00066136

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Data from the initial participants were analyzed to support an NIH grant submission, leading to NIH funding of a new protocol to expand on the initial results.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 7 participants (actual)
Sponsor: Wake Forest University Health Sciences · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 4 Nov 2020
Primary completion: 25 Nov 2020
Completion: 25 Nov 2020
First posted: 16 Jun 2020
Last update posted: 11 Sept 2025
Conditions: Osteoarthritis, Knee · Healthy

Timeline

1 trial · 1 stopped early · 1 with posted results

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

20202021

Ph 2
Generate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects
NCT04431206
4 Nov 2020 to 25 Nov 2020
Terminated
Terminated

Registry summary

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

This is a study of participants that will receive an intravenous (IV) infusion of oxytocin (naturally occurring hormone that is made in the brain). 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 IV catheter placed. After placement of the IV catheter oxytocin will be given by IV infusion. Investigators will perform some tests to evaluate how oxytocin changes perceptions on the skin. Investigators will study a painful perception by placing a probe on the skin and heating it to 113 -117 degrees Fahrenheit (F) for 5 minutes. Each study participant will score any pain that is experienced on a 0 to 10 scale, and most people find that pain rises during the 5 minutes, but remains mild, usually around only 1 or 2 on the 0 to 10 scale. The 5 minute heating temperature will be determined according to the subjects pain rating during the screening visit. The main goal of the study is to determine the effect of oxytocin during and after a fixed rate intravenous infusion on reduction in pain to a sustained heat stimulus in order to generate a model for peripheral analgesia.

Interventions

OxytocinDrug

Arms4

Other
Verbal pain score at 2 minutes
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 2 minutes after starting the intervention, then every 15 minutes for 60 minutes
Other
Verbal pain score at 5 minutes
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 5 minutes after starting the intervention, then every 15 minutes for 60 minutes
Other
Verbal pain score at 7 minutes
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 7 minutes after starting the intervention, then every 15 minutes for 60 minutes
Other
Verbal pain score at 10 minutes
Verbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 10 minutes after starting the intervention, then every 15 minutes for 60 minutes

Primary outcomes5

Outcomes the sponsor listed as primary.

First Verbal Pain Score After Beginning IV Oxytocin Infusion
Time frame · 2-10 minutes after starting oxytocin infusion, depending on Arm
Registry description
Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C 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 is determined by pain rating during screening visit.
Second Verbal Pain Score After Beginning IV Oxytocin Infusion
Time frame · 17-25 minutes after starting oxytocin infusion, depending on Arm
Registry description
Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C 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 is determined by pain rating during screening visit.
Third Verbal Pain Score After Beginning IV Oxytocin Infusion
Time frame · 32-40 minutes after starting oxytocin infusion, depending on Arm
Registry description
Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C 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 is determined by pain rating during screening visit.
Fourth Verbal Pain Score After Beginning IV Oxytocin Infusion
Time frame · 47-55 minutes after starting oxytocin infusion, depending on Arm
Registry description
Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C 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 is determined by pain rating during screening visit.
Fifth Verbal Pain Score After Beginning IV Oxytocin Infusion
Time frame · 62-70 minutes after starting oxytocin infusion, depending on Arm
Registry description
Pain at the end of 5 minutes of heating the skin to 45 - 47 degrees C 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 is determined by 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· 2-10 minutes after starting oxytocin infusion, depending on Arm

First Verbal Pain Score After Beginning IV Oxytocin Infusion

Group	Value (units on a scale)
Verbal Pain Score at 2 Minutes	3.5
Verbal Pain Score at 5 Minutes	4.0
Verbal Pain Score at 7 Minutes	3.5
Verbal Pain Score at 10 Minutes	1.5

Primary outcomeMean· 17-25 minutes after starting oxytocin infusion, depending on Arm

Second Verbal Pain Score After Beginning IV Oxytocin Infusion

Group	Value (units on a scale)
Verbal Pain Score at 2 Minutes	1.5
Verbal Pain Score at 5 Minutes	3.0
Verbal Pain Score at 7 Minutes	1.5
Verbal Pain Score at 10 Minutes	1.0

Primary outcomeMean· 32-40 minutes after starting oxytocin infusion, depending on Arm

Third Verbal Pain Score After Beginning IV Oxytocin Infusion

Group	Value (units on a scale)
Verbal Pain Score at 2 Minutes	3.0
Verbal Pain Score at 5 Minutes	4.0
Verbal Pain Score at 7 Minutes	1.0
Verbal Pain Score at 10 Minutes	1.0

Primary outcomeMean· 47-55 minutes after starting oxytocin infusion, depending on Arm

Fourth Verbal Pain Score After Beginning IV Oxytocin Infusion

Group	Value (units on a scale)
Verbal Pain Score at 2 Minutes	2.0
Verbal Pain Score at 5 Minutes	3.0
Verbal Pain Score at 7 Minutes	2.0
Verbal Pain Score at 10 Minutes	1.0

Primary outcomeMean· 62-70 minutes after starting oxytocin infusion, depending on Arm

Fifth Verbal Pain Score After Beginning IV Oxytocin Infusion

Group	Value (units on a scale)
Verbal Pain Score at 2 Minutes	3.0
Verbal Pain Score at 5 Minutes	2.0
Verbal Pain Score at 7 Minutes	1.5
Verbal Pain Score at 10 Minutes	0.5

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 2 MinutesVerbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 2 minutes after starting the intervention, then every 15 minutes for 60 minutes Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0	0 / 2	0 / 2	0 / 2
Verbal Pain Score at 5 MinutesVerbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 5 minutes after starting the intervention, then every 15 minutes for 60 minutes Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0	0 / 1	0 / 1	0 / 1
Verbal Pain Score at 7 MinutesVerbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 7 minutes after starting the intervention, then every 15 minutes for 60 minutes Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0	0 / 2	0 / 2	0 / 2
Verbal Pain Score at 10 MinutesVerbal pain score is recorded at the end of 5 minutes of heating the skin. In this arm the first score is obtained at 10 minutes after starting the intervention, then every 15 minutes for 60 minutes Oxytocin: Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0	0 / 2	0 / 2	0 / 2

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 °C to the lower calf.

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