Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 1/2 Prospective Double-blind, Placebo-controlled Randomized Clinical Trial Using Losartan to Treat Grade II and III Hamstring Strains

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02263729
Recruitment Status : Recruiting
First Posted : October 13, 2014
Last Update Posted : January 12, 2021
Sponsor:
Collaborators:
Brooke Army Medical Center
Wake Forest University
Information provided by (Responsible Party):
James J. Irrgang, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 26, 2014
First Posted Date  ICMJE October 13, 2014
Last Update Posted Date January 12, 2021
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2014)
  • Reported effects of losartan for hamstring injury for safety and tolerability [ Time Frame: 4 weeks ]
    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.
  • Recovery of hamstring muscle function and structure [ Time Frame: 6 months ]
    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
  • Return to prior level of function [ Time Frame: 12 months ]
    Return to prior level of function will be measured by the number of days from injury to full, unrestricted return to practice.
  • Recurrence of injury [ Time Frame: 12 months ]
    Number of recurrent injuries will be monitored during the duration of the subjects participation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1/2 Prospective Double-blind, Placebo-controlled Randomized Clinical Trial Using Losartan to Treat Grade II and III Hamstring Strains
Official Title  ICMJE Phase 1/2 Prospective Double-blind, Placebo-controlled Randomized Clinical Trial Using Losartan to Treat Grade II and III Hamstring Strains
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hamstring Injury
Intervention  ICMJE
  • Drug: Losartan
  • Drug: placebo
Study Arms  ICMJE
  • Active Comparator: losartan
    Subjects will taken 50mg of losartan per day for 4 weeks
    Intervention: Drug: Losartan
  • Placebo Comparator: placebo
    Subjects will be given placebo to replicate appearance of losartan pills. Placebo pill will be taken once per day.
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 8, 2014)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. 18 years of age and older;
  2. Have had grade II or III hamstring injury within the 7 days prior to enrollment;
  3. Greater than 100 hours per year in Level I (football, basketball, or soccer) or Level II (racquet sports, skiing, manual labor occupations/heavy physical work) and activities that require running and sprinting;
  4. Agree to take study medications as prescribed

Exclusion Criteria:

  1. Have had previous hamstring injury on the same side or chronic symptoms;
  2. Have an injury that requires surgical intervention (e.g. avulsion with associated bony involvement, grade III complete tears);
  3. Have concurrent lower back symptoms;
  4. Pregnant or breast feeding;
  5. Is a smoker;
  6. Has contraindications for Losartan therapy (hypersensitivity to Losartan, hepatic involvement);
  7. Currently use angiotensin I converting enzyme inhibitor (ACEI)/ Angiotensin II receptor blocker (ARB);
  8. Have hypertension (blood pressure greater than or equal to 140 mmHg systolic pressure or greater than or equal to 90 mmHg diastolic pressure);
  9. Have hypotension (blood pressure less than or equal to 90 mmHg systolic pressure or less than or equal to 60 mmHg diastolic pressure);
  10. Have orthostatic hypotension defined as a drop in systolic pressure greater than or equal to 2 0mmHg or a drop in diastolic blood pressure greater than or equal to 10 mmHg or reports of lightheadedness or dizziness upon standing;
  11. Have diabetes mellitus, cardiovascular, renal or hepatic co-morbidities;
  12. Have contraindications for MRI - including:

    • Prior surgery for an aneurysm;
    • Have cardiac pacemaker;
    • Have metal fragments in the eyes, brain, or spinal cord from shrapnel, metal work, or welding;
    • Have surgical implants, such as ear implant or neurostimulator;
    • Have a history of claustrophobia;
    • Have a history of not tolerating previous MRI scans without medication
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: James Irrgang, PT,PhD jirrgang@pitt.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02263729
Other Study ID Numbers  ICMJE PRO14050083
W81XWH-13-2-0052 ( Other Grant/Funding Number: Department of Defense )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James J. Irrgang, University of Pittsburgh
Study Sponsor  ICMJE James J. Irrgang
Collaborators  ICMJE
  • Brooke Army Medical Center
  • Wake Forest University
Investigators  ICMJE Not Provided
PRS Account University of Pittsburgh
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP