Oxytocin Pharmacokinetics After Intramuscular Injection
Primary Purpose
Osteoarthritis, Knee
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
About this trial
This is an interventional basic science trial for Osteoarthritis, Knee focused on measuring advanced knee arthritis
Eligibility Criteria
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. 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.
- 5. diagnosis of advanced knee arthritis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oxytocin
Arm Description
Single IM injection Oxytocin 17 micrograms
Outcomes
Primary Outcome Measures
Oxytocin concentration in serum
Amount of Oxytocin in serum measured in picograms/millilitres (pg/ml) after IM Oxytocin administered
Secondary Outcome Measures
Full Information
NCT ID
NCT04427540
First Posted
June 5, 2020
Last Updated
April 7, 2021
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04427540
Brief Title
Oxytocin Pharmacokinetics After Intramuscular Injection
Official Title
Oxytocin Pharmacokinetics After Intramuscular Injection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not initiated; no subjects were consented or enrolled
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study people with knee arthritis so severe that a joint replacement is needed are recruited for a one day study. Study participants will have an intravenous catheter (IV) inserted in the forearm. A single intramuscular (IM) injection of oxytocin (Pitocin®), 17 micrograms will be administered and blood samples will be taken several times over the next 120 minutes. The amount of oxytocin will be measured in the blood samples.
The main purpose of this study is to sample the blood, before and after the administration of oxytocin and calculate the pharmacokinetics (amount of oxytocin in the blood over time) of oxytocin.
Detailed Description
This is an unblinded, sequential study of subjects, all will receive an intramuscular (IM) injection oxytocin 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 people with knee arthritis so severe that a joint replacement is needed are recruited for a one day study. Participants will come to the Clinical Research Unit (CRU) and have an intravenous catheter (IV) inserted in the forearm. Participants will get a single IM injection of oxytocin (Pitocin®), 17 micrograms (10 International Units (IU)) and blood will be taken several times over the next 120 minutes and the amount of oxytocin measured in the blood samples. This information will be analyzed by another group at Stanford University in the pharmacokinetics/pharmacodynamics (PK/PD) Core part of this application. The Core group at Stanford will use mathematics to fit the amount of oxytocin over time as it disappears from blood to a formula, called pharmacokinetics. The effect of subject age, sex, race, ethnicity and weight on the pharmacokinetics of oxytocin will be tested for, since these things can affect how quickly drugs circulate in the blood and are important to better adjust the dose of drug to the individual.
The main purpose of this study is to sample the blood and calculate the pharmacokinetics of oxytocin. The research participants will not benefit from this study, but the knowledge investigators get will be important not only to adjust oxytocin dose to individuals, but to study its possible effects on pain in a very standardized way. The sample size chosen is needed to get an accurate estimate for the parameters in the pharmacokinetic model for the population, not just the subjects in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
advanced knee arthritis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single IM injection of Oxytocin 17 micrograms
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
Single IM injection Oxytocin 17 micrograms
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
Oxytocin 10 micrograms IM
Primary Outcome Measure Information:
Title
Oxytocin concentration in serum
Description
Amount of Oxytocin in serum measured in picograms/millilitres (pg/ml) after IM Oxytocin administered
Time Frame
1 minute post administration to 120 minutes post administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
5. diagnosis of advanced knee arthritis
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James C Eisenach, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Oxytocin Pharmacokinetics After Intramuscular Injection
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