Status:
WITHDRAWN
A Study of Oxytocin PK After IV Administration in Healthy Subjects and Advanced Knee Arthritis Subjects
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to sample the blood and calculate the pharmacokinetics (PK) of oxytocin. This is an unblinded, sequential study of subjects, all of whom will receive an intravenous ...
Detailed Description
This is an unblinded, sequential study of subjects; all participants will receive an infusion of oxytocin with blood samples taken thereafter in order to create a formula to describe the concentration...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04429880
Start Date
January 1 2023
End Date
January 1 2024
Last Update
August 12 2025
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