Estimate Serum Oxytocin PD Range in the Periphery

NCT04431193 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: IRB00066130
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to define the maximum effect oxytocin (naturally occurring hormone that is made in the brain) has on pain from a 5 minute heat probe applied to the skin and to get an estimate for the relationship between the amount of pain relief at different amounts of oxytocin in the blood. This is a study of participants that will receive an intravenous (IV) infusion of oxytocin (naturally occurring hormone that is made in the brain) with blood samples taken thereafter in order to create a formula to describe the concentrations of oxytocin in the blood over time (pharmacokinetics). In this study healthy volunteers and people with knee arthritis so severe that there is a need for a joint replacement are recruited for a one day study. Each study participant will have 2 IV catheters placed (one in each arm). After placement of the IV catheters, 4 different levels of oxytocin will be given by IV infusion. Blood samples will be taken before the infusion begins and after each different level of the infusion. The blood will be drawn through the second IV catheter. The study team will also do some tests to get a rough idea of how oxytocin changes perceptions on the skin and how this relates to the amount of oxytocin in the blood at the same time. 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.

Conditions

Osteoarthritis, Knee

Keywords

advanced knee arthritis

Outcome Measures

Primary Outcomes (8)

• Pharmacodynamics of heat pain after oxytocin

  Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

  Baseline before any infusion 0 minutes

• Pharmacodynamics of heat pain oxytocin 16 pg/ml

  Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

  Before Oxytocin infusion 15 minutes after baseline

• Pharmacodynamics of heat pain oxytocin 64 pg/ml

  Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

  Before Oxytocin infusion 30 minutes after baseline

• Pharmacodynamics of heat pain oxytocin 256 pg/ml

  Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

  Before Oxytocin infusion 45 minutes after baseline

• Pharmacodynamics of heat pain oxytocin 4pg/ml

  Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

  After Oxytocin infusion 14 minutes after baseline

• Pharmacodynamics of heat pain oxytocin 16 pg/ml

  Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

  After Oxytocin infusion 29 minutes after baseline

• Pharmacodynamics of heat pain oxytocin 64pg/ml

  Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

  After Oxytocin infusion 44 minutes after baseline

• Pharmacodynamics of heat pain oxytocin 256 pg/ml

  Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.

  After Oxytocin infusion 59 minutes after baseline

Secondary Outcomes (4)

• Pharmacokinetics of oxytocin in serum 4pg/ml

  After Oxytocin infusion 15 minutes after baseline

• Pharmacokinetics of oxytocin in serum 16 pg/ml

  After Oxytocin infusion 30 minutes after baseline

• Pharmacokinetics of oxytocin in serum 64pg/ml

  After Oxytocin infusion 45 minutes after baseline

• Pharmacokinetics of oxytocin in serum 256pg/ml

  After Oxytocin infusion 60 minutes after baseline

Study Arms (4)

Oxytocin 4 picogram/millilitre

EXPERIMENTAL

Oxytocin infused to maintain serum concentration of 4 picogram/millilitre

Drug: Oxytocin

Oxytocin 16 picogram/millilitre

EXPERIMENTAL

Oxytocin infused to maintain serum concentration of 16 picogram/millilitre

Drug: Oxytocin

Oxytocin 64 picogram/millilitre

EXPERIMENTAL

Oxytocin infused to maintain serum concentration of 64 picogram/millilitre

Drug: Oxytocin

Oxytocin 256 picogram/millilitre

EXPERIMENTAL

Oxytocin infused to maintain serum concentration of 256 picogram/millilitre

Drug: Oxytocin

Interventions

Oxytocin DRUG

Oxytocin infused to maintain serum concentrations of 4, 16, 64, and 256 picogram/millilitre

Also known as: Pitocin

Oxytocin 16 picogram/millilitre; Oxytocin 256 picogram/millilitre; Oxytocin 4 picogram/millilitre; Oxytocin 64 picogram/millilitre

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.

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

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Oxytocin infused to maintain serum concentrations of 4, 16, 64, and 256 picogram/millilitre

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 16, 2020
• Study Start: December 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 30, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)