Generate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects

NCT04431206 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: IRB00066136
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee; Healthy

Outcome Measures

Primary Outcomes (5)

• First Verbal Pain Score After Beginning IV Oxytocin Infusion

  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.

  2-10 minutes after starting oxytocin infusion, depending on Arm

• Second Verbal Pain Score After Beginning IV Oxytocin Infusion

  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.

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

• Third Verbal Pain Score After Beginning IV Oxytocin Infusion

  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.

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

• Fourth Verbal Pain Score After Beginning IV Oxytocin Infusion

  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.

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

• Fifth Verbal Pain Score After Beginning IV Oxytocin Infusion

  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.

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

Study Arms (4)

Verbal pain score at 2 minutes

OTHER

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

Drug: Oxytocin

Verbal pain score at 5 minutes

OTHER

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

Drug: Oxytocin

Verbal pain score at 7 minutes

OTHER

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

Drug: Oxytocin

Verbal pain score at 10 minutes

OTHER

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

Drug: Oxytocin

Interventions

Oxytocin DRUG

Oxytocin, 8.2 IU, administered by 30minute IV infusion starting at time 0

Also known as: Pitocin

Verbal pain score at 10 minutes; Verbal pain score at 2 minutes; Verbal pain score at 5 minutes; Verbal pain score at 7 minutes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \> 18 and \< 75 years of age, Body Mass Index (BMI) \<40.
• 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.
• 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.
• 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.

You may not qualify if:

• Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
• 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
• 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
• Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
• Subjects with current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval.
• 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.
• Subjects with a known latex allergy.
• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The study was paused after the completion of 7 healthy participants and data were analyzed for the purpose of a grant application revision. The results led to a heavily revised proposed study of pharmacodynamic modeling, and when the grant was funded, this new study was approved and performed under a different IRB approval and CTG registration.

Results Point of Contact

• Title: Dr. James Eisenach
• Organization: Wake Forest University School of Medicine

james.eisenach@advocatehealth.org

3367164182

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All arms receive the same IV oxytocin 30-minute infusion. Participants are randomly assigned for heat pain testing every 15 min for 60 min beginning at either 2, 5, 7, or 10 minutes from the beginning of the IV oxytocin infusion.

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 16, 2020
• Study Start: November 4, 2020
• Primary Completion: November 25, 2020
• Study Completion: November 25, 2020
• Last Updated: September 11, 2025
• Results First Posted: August 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available upon posting results to a preprint server, anticipated to occur by the end of the first quarter of 2026
• Access Criteria: For the purpose of pharmacokinetic / pharmacodynamic modeling or meta-analyses / review publications.

Locations

US (1)