<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/NCT04431193</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00066130</org_study_id>
    <nct_id>NCT04431193</nct_id>
  </id_info>
  <brief_title>Estimate Serum Oxytocin PD Range in the Periphery</brief_title>
  <official_title>Estimate Serum Oxytocin Pharmacodynamic Range in the Periphery</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>
      The main purpose of this study is to define the maximum effect oxytocin (naturally occurring&#xD;
      hormone that is made in the brain) has on pain from a 5 minute heat probe applied to the skin&#xD;
      and to get an estimate for the relationship between the amount of pain relief at different&#xD;
      amounts of oxytocin in the blood.&#xD;
&#xD;
      This is a study of participants that will receive an intravenous (IV) infusion of oxytocin&#xD;
      (naturally occurring hormone that is made in the brain) with blood samples taken thereafter&#xD;
      in order to create a formula to describe the concentrations of oxytocin in the blood over&#xD;
      time (pharmacokinetics).&#xD;
&#xD;
      In this study healthy volunteers and people with knee arthritis so severe that there is a&#xD;
      need for a joint replacement are recruited for a one day study. Each study participant will&#xD;
      have 2 IV catheters placed (one in each arm). After placement of the IV catheters, 4&#xD;
      different levels of oxytocin will be given by IV infusion. Blood samples will be taken before&#xD;
      the infusion begins and after each different level of the infusion. The blood will be drawn&#xD;
      through the second IV catheter.&#xD;
&#xD;
      The study team will also do some tests to get a rough idea of how oxytocin changes&#xD;
      perceptions on the skin and how this relates to the amount of oxytocin in the blood at the&#xD;
      same time. The study team will study a painful perception by placing a probe on the skin and&#xD;
      heating it to 113 degrees Fahrenheit for 5 minutes. Each study participant will score any&#xD;
      pain that is experienced on a 0 to 10 scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an unblinded, sequential study in which all participants will receive intravenous&#xD;
      (IV) infusions of oxytocin in the same manner (except for safety reasons an adjustment at the&#xD;
      highest level after review of the first 7 study participants as indicated in safety plan). In&#xD;
      this study healthy people and with those with knee arthritis so severe that a joint&#xD;
      replacement is needed are recruited for a one day study. Study participants will come to the&#xD;
      Clinical Research Unit (CRU) and two IVs inserted; one in each forearm. Study participants&#xD;
      will have an intravenous infusion of oxytocin at infusion rates that will result in a steady&#xD;
      concentration of oxytocin in the blood for 15 minutes. The infusion rate will be increased&#xD;
      every 15 minutes for a total of 4 targeted levels. Blood (5 millilitres (ml)) will be&#xD;
      withdrawn through the IV not being used for infusion at the end of each of these infusion&#xD;
      levels and the amount of oxytocin measured in the blood samples. This information will be&#xD;
      analyzed by another group at Stanford University in the Pharmacokinetics/Pharmacodynamics&#xD;
      (PK/PD) Core part of this application. The core group at Stanford University will use&#xD;
      mathematics to test the accuracy of the infusion to target the blood concentration.&#xD;
&#xD;
      The main purpose of this study is to define the maximum effect oxytocin has on pain from a 5&#xD;
      minute heat probe applied to the skin and to get an estimate for the relationship between the&#xD;
      amounts of pain relief at different amounts of oxytocin in the blood. The study team will use&#xD;
      a commercially available device (Medoc TSA II) to heat a probe on the skin to 113 degrees&#xD;
      Fahrenheit (45 degrees Celsius) for 5 minutes. Study participants will score any pain noted&#xD;
      on a 0 to 10 scale, and most people find that pain rises during the 5 minutes, but remains&#xD;
      mild, usually around only 1 or 2 on the 0 to 10 scale. The study team will do this 5 times&#xD;
      during the study, once before the infusion and once during each of the 4 levels of infusion.&#xD;
      From this the study team will calculate how the amount of oxytocin in the blood affects pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study will be replaced by a revised study protocol&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2023</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Oxytocin infused to maintain serum concentrations of 4, 16, 64, and 256 picogram/millilitre</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain after oxytocin</measure>
    <time_frame>Baseline before any infusion 0 minutes</time_frame>
    <description>Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain oxytocin 16 pg/ml</measure>
    <time_frame>Before Oxytocin infusion 15 minutes after baseline</time_frame>
    <description>Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain oxytocin 64 pg/ml</measure>
    <time_frame>Before Oxytocin infusion 30 minutes after baseline</time_frame>
    <description>Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain oxytocin 256 pg/ml</measure>
    <time_frame>Before Oxytocin infusion 45 minutes after baseline</time_frame>
    <description>Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain oxytocin 4pg/ml</measure>
    <time_frame>After Oxytocin infusion 14 minutes after baseline</time_frame>
    <description>Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain oxytocin 16 pg/ml</measure>
    <time_frame>After Oxytocin infusion 29 minutes after baseline</time_frame>
    <description>Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain oxytocin 64pg/ml</measure>
    <time_frame>After Oxytocin infusion 44 minutes after baseline</time_frame>
    <description>Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacodynamics of heat pain oxytocin 256 pg/ml</measure>
    <time_frame>After Oxytocin infusion 59 minutes after baseline</time_frame>
    <description>Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum 4pg/ml</measure>
    <time_frame>After Oxytocin infusion 15 minutes after baseline</time_frame>
    <description>Blood will be sampled at the end of each infusion targeted to a set blood concentration of oxytocin. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration. The accuracy of the pharmacokinetics will be assessed by difference between targeted and observed oxytocin concentrations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum 16 pg/ml</measure>
    <time_frame>After Oxytocin infusion 30 minutes after baseline</time_frame>
    <description>Blood will be sampled at the end of each infusion targeted to a set blood concentration of oxytocin. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration. The accuracy of the pharmacokinetics will be assessed by difference between targeted and observed oxytocin concentrations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum 64pg/ml</measure>
    <time_frame>After Oxytocin infusion 45 minutes after baseline</time_frame>
    <description>Blood will be sampled at the end of each infusion targeted to a set blood concentration of oxytocin. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration. The accuracy of the pharmacokinetics will be assessed by difference between targeted and observed oxytocin concentrations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics of oxytocin in serum 256pg/ml</measure>
    <time_frame>After Oxytocin infusion 60 minutes after baseline</time_frame>
    <description>Blood will be sampled at the end of each infusion targeted to a set blood concentration of oxytocin. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration. The accuracy of the pharmacokinetics will be assessed by difference between targeted and observed oxytocin concentrations.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Oxytocin 4 picogram/millilitre</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxytocin infused to maintain serum concentration of 4 picogram/millilitre</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxytocin 16 picogram/millilitre</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxytocin infused to maintain serum concentration of 16 picogram/millilitre</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxytocin 64 picogram/millilitre</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxytocin infused to maintain serum concentration of 64 picogram/millilitre</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxytocin 256 picogram/millilitre</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxytocin infused to maintain serum concentration of 256 picogram/millilitre</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Oxytocin infused to maintain serum concentrations of 4, 16, 64, and 256 picogram/millilitre</description>
    <arm_group_label>Oxytocin 16 picogram/millilitre</arm_group_label>
    <arm_group_label>Oxytocin 256 picogram/millilitre</arm_group_label>
    <arm_group_label>Oxytocin 4 picogram/millilitre</arm_group_label>
    <arm_group_label>Oxytocin 64 picogram/millilitre</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. For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90&#xD;
             mmHg) resting heart rate 45-100 beats per minute) without medication. For knee&#xD;
             arthritis subjects, normal blood pressure or, for those with hypertension, pressure&#xD;
             controlled with anti-hypertensives and with a resting heart rate 45-100 beats per&#xD;
             minute.&#xD;
&#xD;
          4. Female subjects of child-bearing potential and those &lt; 1 year post-menopausal, must be&#xD;
             practicing highly effective methods of birth control such as hormonal methods (e.g.,&#xD;
             combined oral, implantable, injectable, or transdermal contraceptives), double barrier&#xD;
             methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal jellies or&#xD;
             cream), or total abstinence from heterosexual intercourse for a minimum of 1 full&#xD;
             cycle before study drug administration.&#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 the&#xD;
             Principal Investigator, would place the subject at increased risk (active gynecologic&#xD;
             disease in which increased tone would be detrimental e.g., uterine fibroids with&#xD;
             ongoing bleeding), compromise the subject's compliance with study procedures, or&#xD;
             compromise the quality of the data&#xD;
&#xD;
          3. Women who are pregnant (positive result for serum pregnancy test at screening visit),&#xD;
             women who are currently nursing or lactating, women that have been pregnant within 2&#xD;
             years&#xD;
&#xD;
          4. Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines&#xD;
             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>Accepts Healthy Volunteers</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>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>December 28, 2022</last_update_submitted>
  <last_update_submitted_qc>December 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2022</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/NCT04431193
org study id: IRB00066130
nct id: NCT04431193
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The main purpose of this study is to define the maximum effect oxytocin (naturally occurring
      hormone that is made in the brain) has on pain from a 5 minute heat probe applied to the skin
      and to get an estimate for the relationship between the amount of pain relief at different
      amounts of oxytocin in the blood.

      This is a study of participants that will receive an intravenous (IV) infusion of oxytocin
      (naturally occurring hormone that is made in the brain) 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 healthy volunteers and people with knee arthritis so severe that there is a
      need for a joint replacement are recruited for a one day study. Each study participant will
      have 2 IV catheters placed (one in each arm). After placement of the IV catheters, 4
      different levels of oxytocin will be given by IV infusion. Blood samples will be taken before
      the infusion begins and after each different level of the infusion. The blood will be drawn
      through the second IV catheter.

      The study team will also do some tests to get a rough idea of how oxytocin changes
      perceptions on the skin and how this relates to the amount of oxytocin in the blood at the
      same time. The study team will study a painful perception by placing a probe on the skin and
      heating it to 113 degrees Fahrenheit for 5 minutes. Each study participant will score any
      pain that is experienced on a 0 to 10 scale.
This is an unblinded, sequential study in which all participants will receive intravenous
      (IV) infusions of oxytocin in the same manner (except for safety reasons an adjustment at the
      highest level after review of the first 7 study participants as indicated in safety plan). In
      this study healthy people and with those with knee arthritis so severe that a joint
      replacement is needed are recruited for a one day study. Study participants will come to the
      Clinical Research Unit (CRU) and two IVs inserted; one in each forearm. Study participants
      will have an intravenous infusion of oxytocin at infusion rates that will result in a steady
      concentration of oxytocin in the blood for 15 minutes. The infusion rate will be increased
      every 15 minutes for a total of 4 targeted levels. Blood (5 millilitres (ml)) will be
      withdrawn through the IV not being used for infusion at the end of each of these infusion
      levels 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 University will use
      mathematics to test the accuracy of the infusion to target the blood concentration.

      The main purpose of this study is to define the maximum effect oxytocin has on pain from a 5
      minute heat probe applied to the skin and to get an estimate for the relationship between the
      amounts of pain relief at different amounts of oxytocin in the blood. The study team will use
      a commercially available device (Medoc TSA II) to heat a probe on the skin to 113 degrees
      Fahrenheit (45 degrees Celsius) for 5 minutes. Study participants will score any pain noted
      on a 0 to 10 scale, and most people find that pain rises during the 5 minutes, but remains
      mild, usually around only 1 or 2 on the 0 to 10 scale. The study team will do this 5 times
      during the study, once before the infusion and once during each of the 4 levels of infusion.
      From this the study team will calculate how the amount of oxytocin in the blood affects pain.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Oxytocin infused to maintain serum concentrations of 4, 16, 64, and 256 picogram/millilitre
primary purpose: Basic Science
masking: None (Open Label)
measure: Pharmacodynamics of heat pain after oxytocin
time frame: Baseline before any infusion 0 minutes
description: Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
measure: Pharmacodynamics of heat pain oxytocin 16 pg/ml
time frame: Before Oxytocin infusion 15 minutes after baseline
description: Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
measure: Pharmacodynamics of heat pain oxytocin 64 pg/ml
time frame: Before Oxytocin infusion 30 minutes after baseline
description: Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
measure: Pharmacodynamics of heat pain oxytocin 256 pg/ml
time frame: Before Oxytocin infusion 45 minutes after baseline
description: Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
measure: Pharmacodynamics of heat pain oxytocin 4pg/ml
time frame: After Oxytocin infusion 14 minutes after baseline
description: Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
measure: Pharmacodynamics of heat pain oxytocin 16 pg/ml
time frame: After Oxytocin infusion 29 minutes after baseline
description: Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
measure: Pharmacodynamics of heat pain oxytocin 64pg/ml
time frame: After Oxytocin infusion 44 minutes after baseline
description: Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
measure: Pharmacodynamics of heat pain oxytocin 256 pg/ml
time frame: After Oxytocin infusion 59 minutes after baseline
description: Pain will be measured using a verbal Pain Scale 0-10. 0 is equivalent to NO PAIN and 10 is equivalent to WORST PAIN IMAGINABLE.
measure: Pharmacokinetics of oxytocin in serum 4pg/ml
time frame: After Oxytocin infusion 15 minutes after baseline
description: Blood will be sampled at the end of each infusion targeted to a set blood concentration of oxytocin. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration. The accuracy of the pharmacokinetics will be assessed by difference between targeted and observed oxytocin concentrations.
measure: Pharmacokinetics of oxytocin in serum 16 pg/ml
time frame: After Oxytocin infusion 30 minutes after baseline
description: Blood will be sampled at the end of each infusion targeted to a set blood concentration of oxytocin. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration. The accuracy of the pharmacokinetics will be assessed by difference between targeted and observed oxytocin concentrations.
measure: Pharmacokinetics of oxytocin in serum 64pg/ml
time frame: After Oxytocin infusion 45 minutes after baseline
description: Blood will be sampled at the end of each infusion targeted to a set blood concentration of oxytocin. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration. The accuracy of the pharmacokinetics will be assessed by difference between targeted and observed oxytocin concentrations.
measure: Pharmacokinetics of oxytocin in serum 256pg/ml
time frame: After Oxytocin infusion 60 minutes after baseline
description: Blood will be sampled at the end of each infusion targeted to a set blood concentration of oxytocin. Serum will be separated, rapidly frozen, and later analyzed for oxytocin concentration. The accuracy of the pharmacokinetics will be assessed by difference between targeted and observed oxytocin concentrations.
arm group label: Oxytocin 4 picogram/millilitre
arm group type: Experimental
description: Oxytocin infused to maintain serum concentration of 4 picogram/millilitre
arm group label: Oxytocin 16 picogram/millilitre
arm group type: Experimental
description: Oxytocin infused to maintain serum concentration of 16 picogram/millilitre
arm group label: Oxytocin 64 picogram/millilitre
arm group type: Experimental
description: Oxytocin infused to maintain serum concentration of 64 picogram/millilitre
arm group label: Oxytocin 256 picogram/millilitre
arm group type: Experimental
description: Oxytocin infused to maintain serum concentration of 256 picogram/millilitre
intervention type: Drug
intervention name: Oxytocin
description: Oxytocin infused to maintain serum concentrations of 4, 16, 64, and 256 picogram/millilitre
arm group label: Oxytocin 16 picogram/millilitre
arm group label: Oxytocin 256 picogram/millilitre
arm group label: Oxytocin 4 picogram/millilitre
arm group label: Oxytocin 64 picogram/millilitre
other name: Pitocin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James C Eisenach, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee
mesh term: Oxytocin
sharing ipd: No