<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04427540</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00065842</org_study_id>
    <nct_id>NCT04427540</nct_id>
  </id_info>
  <brief_title>Oxytocin Pharmacokinetics After Intramuscular Injection</brief_title>
  <official_title>Oxytocin Pharmacokinetics After Intramuscular Injection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study people with knee arthritis so severe that a joint replacement is needed are&#xD;
      recruited for a one day study. Study participants will have an intravenous catheter (IV)&#xD;
      inserted in the forearm. A single intramuscular (IM) injection of oxytocin (Pitocin®), 17&#xD;
      micrograms will be administered and blood samples will be taken several times over the next&#xD;
      120 minutes. The amount of oxytocin will be measured in the blood samples.&#xD;
&#xD;
      The main purpose of this study is to sample the blood, before and after the administration of&#xD;
      oxytocin and calculate the pharmacokinetics (amount of oxytocin in the blood over time) of&#xD;
      oxytocin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an unblinded, sequential study of subjects, all will receive an intramuscular (IM)&#xD;
      injection oxytocin with blood samples taken thereafter in order to create a formula to&#xD;
      describe the concentrations of oxytocin in the blood over time (pharmacokinetics). In this&#xD;
      study people with knee arthritis so severe that a joint replacement is needed are recruited&#xD;
      for a one day study. Participants will come to the Clinical Research Unit (CRU) and have an&#xD;
      intravenous catheter (IV) inserted in the forearm. Participants will get a single IM&#xD;
      injection of oxytocin (Pitocin®), 17 micrograms (10 International Units (IU)) and blood will&#xD;
      be taken several times over the next 120 minutes and the amount of oxytocin measured in the&#xD;
      blood samples. This information will be analyzed by another group at Stanford University in&#xD;
      the pharmacokinetics/pharmacodynamics (PK/PD) Core part of this application. The Core group&#xD;
      at Stanford will use mathematics to fit the amount of oxytocin over time as it disappears&#xD;
      from blood to a formula, called pharmacokinetics. The effect of subject age, sex, race,&#xD;
      ethnicity and weight on the pharmacokinetics of oxytocin will be tested for, since these&#xD;
      things can affect how quickly drugs circulate in the blood and are important to better adjust&#xD;
      the dose of drug to the individual.&#xD;
&#xD;
      The main purpose of this study is to sample the blood and calculate the pharmacokinetics of&#xD;
      oxytocin. The research participants will not benefit from this study, but the knowledge&#xD;
      investigators get will be important not only to adjust oxytocin dose to individuals, but to&#xD;
      study its possible effects on pain in a very standardized way. The sample size chosen is&#xD;
      needed to get an accurate estimate for the parameters in the pharmacokinetic model for the&#xD;
      population, not just the subjects in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was not initiated; no subjects were consented or enrolled&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single IM injection of Oxytocin 17 micrograms</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxytocin concentration in serum</measure>
    <time_frame>1 minute post administration to 120 minutes post administration</time_frame>
    <description>Amount of Oxytocin in serum measured in picograms/millilitres (pg/ml) after IM Oxytocin administered</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single IM injection Oxytocin 17 micrograms</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Oxytocin 10 micrograms IM</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>Pitocin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Male or female &gt; 18 and &lt; 75 years of age, Body Mass Index (BMI) &lt;40.&#xD;
&#xD;
          -  2. Generally in good health as determined by the Principal Investigator based on prior&#xD;
             medical history, American Society of Anesthesiologists physical status 1, 2, or 3.&#xD;
&#xD;
          -  3. Normal blood pressure or, for those with hypertension, pressure controlled with&#xD;
             anti-hypertensives and with a resting heart rate 45-100 beats per minute.&#xD;
&#xD;
          -  4. Female subjects of child-bearing potential and those &lt; 1 year post-menopausal, must&#xD;
             be practicing highly effective methods of birth control such as hormonal methods&#xD;
             (e.g., combined oral, implantable, injectable, or transdermal contraceptives), double&#xD;
             barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal&#xD;
             jellies or cream), or total abstinence from heterosexual intercourse for a minimum of&#xD;
             1 full cycle before study drug administration.&#xD;
&#xD;
          -  5. diagnosis of advanced knee arthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®&#xD;
&#xD;
          -  2. Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of&#xD;
             the Principal Investigator, would place the subject at increased risk (active&#xD;
             gynecologic disease in which increased tone would be detrimental e.g., uterine&#xD;
             fibroids with ongoing bleeding), compromise the subject's compliance with study&#xD;
             procedures, or compromise the quality of the data&#xD;
&#xD;
          -  3. Women who are pregnant (positive result for serum pregnancy test at screening&#xD;
             visit), women who are currently nursing or lactating, women that have been pregnant&#xD;
             within 2 years&#xD;
&#xD;
          -  4. Subjects with neuropathy, chronic pain, diabetes mellitus, or taking&#xD;
             benzodiazepines or pain medications on a daily basis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James C Eisenach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>April 7, 2021</last_update_submitted>
  <last_update_submitted_qc>April 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>advanced knee arthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04427540
org study id: IRB00065842
nct id: NCT04427540
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single IM injection of Oxytocin 17 micrograms
primary purpose: Basic Science
masking: None (Open Label)
measure: Oxytocin concentration in serum
time frame: 1 minute post administration to 120 minutes post administration
description: Amount of Oxytocin in serum measured in picograms/millilitres (pg/ml) after IM Oxytocin administered
arm group label: Oxytocin
arm group type: Experimental
description: Single IM injection Oxytocin 17 micrograms
intervention type: Drug
intervention name: Oxytocin
description: Oxytocin 10 micrograms IM
arm group label: Oxytocin
other name: Pitocin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: James C Eisenach, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee
mesh term: Oxytocin
sharing ipd: No