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

  • STATUS
    Recruiting
  • days left to enroll
    86
  • participants needed
    10
  • sponsor
    James J. Irrgang
Updated on 24 March 2022

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.

Details
Condition Hamstring Injury
Treatment Placebo, losartan
Clinical Study IdentifierNCT02263729
SponsorJames J. Irrgang
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

18 years of age and older
Have had grade II or III hamstring injury within the 7 days prior to enrollment
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
Agree to take study medications as prescribed

Exclusion Criteria

Have had previous hamstring injury on the same side or chronic symptoms
Have an injury that requires surgical intervention (e.g. avulsion with associated bony involvement, grade III complete tears)
Have concurrent lower back symptoms
Pregnant or breast feeding
Is a smoker
Has contraindications for Losartan therapy (hypersensitivity to Losartan, hepatic involvement)
Currently use angiotensin I converting enzyme inhibitor (ACEI)/ Angiotensin II receptor blocker (ARB)
Have hypertension (blood pressure greater than or equal to 140 mmHg systolic pressure or greater than or equal to 90 mmHg diastolic pressure)
Have hypotension (blood pressure less than or equal to 90 mmHg systolic pressure or less than or equal to 60 mmHg diastolic pressure)
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
Have diabetes mellitus, cardiovascular, renal or hepatic co-morbidities
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note