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Oxytocin Pharmacokinetics After Intramuscular Injection

Primary Purpose

Osteoarthritis, Knee

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoarthritis, Knee focused on measuring advanced knee arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 5, 2020
    Last Updated
    April 7, 2021
    Sponsor
    Wake Forest University Health Sciences
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    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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