Status:
TERMINATED
Generate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Osteoarthritis, Knee
Healthy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 kn...
Detailed Description
In this study healthy people or those with knee arthritis so severe that they may need joint replacement are recruited for a one day study. Study participants will come to the Clinical Research Unit (...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04431206
Start Date
November 4 2020
End Date
November 25 2020
Last Update
September 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157