<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/NCT02263729</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY19100320</org_study_id>
    <secondary_id>W81XWH-13-2-0052</secondary_id>
    <nct_id>NCT02263729</nct_id>
  </id_info>
  <brief_title>Phase 1/2 Prospective Double-blind, Placebo-controlled Randomized Clinical Trial Using Losartan to Treat Grade II and III Hamstring Strains</brief_title>
  <official_title>Phase 1/2 Prospective Double-blind, Placebo-controlled Randomized Clinical Trial Using Losartan to Treat Grade II and III Hamstring Strains</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>James J. Irrgang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brooke Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wake Forest University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to determine safety and tolerability of Losartan when used for&#xD;
      treatment of an acute grade II or III hamstring strain and determining the effect of losartan&#xD;
      on recovery of hamstring muscle function. Subjects will be adults age 18 and older with grade&#xD;
      2 or 3 hamstring injury who participate in greater than 100 hours per year in Level 1 or&#xD;
      Level 2 athletics or have a similar activities or physical work load (e.g. military&#xD;
      personnel). Subjects will undergo examination, MRI, and functional assessment before, during,&#xD;
      and after 4 weeks of losartan (50mg QD) or placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reported effects of losartan for hamstring injury for safety and tolerability</measure>
    <time_frame>4 weeks</time_frame>
    <description>Directly related to specific aim 1- Side effects, safety, and tolerability will be monitored by measuring vital signs, lab values via blood work, and number of adverse events, serious adverse events, and patient reported side effects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recovery of hamstring muscle function and structure</measure>
    <time_frame>6 months</time_frame>
    <description>Related to specific aim 2, hamstring muscle function of the injured leg will be measured and compared to the contralateral leg using isometric hamstring torque. Hamstring function is measured by comparing pre-treatment MRI to MRI at 6 months post-treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Return to prior level of function</measure>
    <time_frame>12 months</time_frame>
    <description>Return to prior level of function will be measured by the number of days from injury to full, unrestricted return to practice.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recurrence of injury</measure>
    <time_frame>12 months</time_frame>
    <description>Number of recurrent injuries will be monitored during the duration of the subjects participation.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">8</enrollment>
  <condition>Hamstring Injury</condition>
  <arm_group>
    <arm_group_label>losartan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will taken 50mg of losartan per day for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will be given placebo to replicate appearance of losartan pills. Placebo pill will be taken once per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Losartan</intervention_name>
    <arm_group_label>losartan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. 18 years of age and older;&#xD;
&#xD;
          2. Have had grade II or III hamstring injury within the 7 days prior to enrollment;&#xD;
&#xD;
          3. Greater than 100 hours per year in Level I (football, basketball, or soccer) or Level&#xD;
             II (racquet sports, skiing, manual labor occupations/heavy physical work) and&#xD;
             activities that require running and sprinting;&#xD;
&#xD;
          4. Agree to take study medications as prescribed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have had previous hamstring injury on the same side or chronic symptoms;&#xD;
&#xD;
          2. Have an injury that requires surgical intervention (e.g. avulsion with associated bony&#xD;
             involvement, grade III complete tears);&#xD;
&#xD;
          3. Have concurrent lower back symptoms;&#xD;
&#xD;
          4. Pregnant or breast feeding;&#xD;
&#xD;
          5. Is a smoker;&#xD;
&#xD;
          6. Has contraindications for Losartan therapy (hypersensitivity to Losartan, hepatic&#xD;
             involvement);&#xD;
&#xD;
          7. Currently use angiotensin I converting enzyme inhibitor (ACEI)/ Angiotensin II&#xD;
             receptor blocker (ARB);&#xD;
&#xD;
          8. Have hypertension (blood pressure greater than or equal to 140 mmHg systolic pressure&#xD;
             or greater than or equal to 90 mmHg diastolic pressure);&#xD;
&#xD;
          9. Have hypotension (blood pressure less than or equal to 90 mmHg systolic pressure or&#xD;
             less than or equal to 60 mmHg diastolic pressure);&#xD;
&#xD;
         10. Have orthostatic hypotension defined as a drop in systolic pressure greater than or&#xD;
             equal to 2 0mmHg or a drop in diastolic blood pressure greater than or equal to 10&#xD;
             mmHg or reports of lightheadedness or dizziness upon standing;&#xD;
&#xD;
         11. Have diabetes mellitus, cardiovascular, renal or hepatic co-morbidities;&#xD;
&#xD;
         12. Have contraindications for MRI - including:&#xD;
&#xD;
               -  Prior surgery for an aneurysm;&#xD;
&#xD;
               -  Have cardiac pacemaker;&#xD;
&#xD;
               -  Have metal fragments in the eyes, brain, or spinal cord from shrapnel, metal&#xD;
                  work, or welding;&#xD;
&#xD;
               -  Have surgical implants, such as ear implant or neurostimulator;&#xD;
&#xD;
               -  Have a history of claustrophobia;&#xD;
&#xD;
               -  Have a history of not tolerating previous MRI scans without medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>James J. Irrgang</investigator_full_name>
    <investigator_title>PT, PhD</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Losartan</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02263729
org study id: STUDY19100320
secondary id: W81XWH-13-2-0052
nct id: NCT02263729
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The goal of this study is to determine safety and tolerability of Losartan when used for
      treatment of an acute grade II or III hamstring strain and determining the effect of losartan
      on recovery of hamstring muscle function. Subjects will be adults age 18 and older with grade
      2 or 3 hamstring injury who participate in greater than 100 hours per year in Level 1 or
      Level 2 athletics or have a similar activities or physical work load (e.g. military
      personnel). Subjects will undergo examination, MRI, and functional assessment before, during,
      and after 4 weeks of losartan (50mg QD) or placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Reported effects of losartan for hamstring injury for safety and tolerability
time frame: 4 weeks
description: Directly related to specific aim 1- Side effects, safety, and tolerability will be monitored by measuring vital signs, lab values via blood work, and number of adverse events, serious adverse events, and patient reported side effects.
measure: Recovery of hamstring muscle function and structure
time frame: 6 months
description: Related to specific aim 2, hamstring muscle function of the injured leg will be measured and compared to the contralateral leg using isometric hamstring torque. Hamstring function is measured by comparing pre-treatment MRI to MRI at 6 months post-treatment
measure: Return to prior level of function
time frame: 12 months
description: Return to prior level of function will be measured by the number of days from injury to full, unrestricted return to practice.
measure: Recurrence of injury
time frame: 12 months
description: Number of recurrent injuries will be monitored during the duration of the subjects participation.
arm group label: losartan
arm group type: Active Comparator
description: Subjects will taken 50mg of losartan per day for 4 weeks
arm group label: placebo
arm group type: Placebo Comparator
description: Subjects will be given placebo to replicate appearance of losartan pills. Placebo pill will be taken once per day.
intervention type: Drug
intervention name: Losartan
arm group label: losartan
intervention type: Drug
intervention name: placebo
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: James J. Irrgang
investigator title: PT, PhD
mesh term: Losartan