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

Sponsor

James J. Irrgang (Other)

Overall Status

Recruiting

CT.gov ID

NCT02263729

Collaborator

Brooke Army Medical Center (U.S. Fed), Wake Forest University (Other)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hamstring Injury	Drug: Losartan Drug: placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: losartan Subjects will taken 50mg of losartan per day for 4 weeks	Drug: Losartan
Placebo Comparator: placebo Subjects will be given placebo to replicate appearance of losartan pills. Placebo pill will be taken once per day.	Drug: placebo

Arm

Intervention/Treatment

Active Comparator: losartan

Subjects will taken 50mg of losartan per day for 4 weeks

Drug: Losartan

Placebo Comparator: placebo

Subjects will be given placebo to replicate appearance of losartan pills. Placebo pill will be taken once per day.

Drug: placebo

Outcome Measures

Primary Outcome Measures

Reported effects of losartan for hamstring injury for safety and tolerability [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 [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 [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 [12 months]
Number of recurrent injuries will be monitored during the duration of the subjects participation.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

James J. Irrgang
Brooke Army Medical Center
Wake Forest University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

James J. Irrgang, PT, PhD, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT02263729

Other Study ID Numbers:

PRO14050083
W81XWH-13-2-0052

First Posted:

Oct 13, 2014

Last Update Posted:

Jan 11, 2022

Last Verified:

Jan 1, 2022

Additional relevant MeSH terms:

Losartan

Study Results

No Results Posted as of Jan 11, 2022