Phase 1/2 Prospective Double-Blind Placebo-Controlled Randomized Clinical Trial of Losartan to Treat Grade II & III Hamstring Strains

NCT ID: NCT02263729

Last Updated: 2024-05-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-10
• Study Completion Date: 2022-12-31

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.

Conditions

Hamstring Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Losartan

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

Group Type: ACTIVE_COMPARATOR

Losartan

Intervention Type: DRUG

Cozaar

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Losartan

Cozaar

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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. Sickle cell anemia/trait;

13. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brooke Army Medical Center

FED

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: collaborator

James J. Irrgang

OTHER

Sponsor Role: lead

Responsible Party

James J. Irrgang

PT, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

James J Irrgang, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

W81XWH-14-2-0003

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY19100320

Identifier Type: -

Identifier Source: org_study_id