Hamstring InjuryPhase 1/2NCT02263729

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

A Phase 1/2 study testing Losartan in people with Hamstring Injury, run by James J. Irrgang at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hamstring Injury
What is being tested?: Losartan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 10 Aug 2016to 31 Dec 2022
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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);

Show all 19Show fewer

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;
Sickle cell anemia/trait;
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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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

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
Being tested: Losartan, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LosartanDrug
Cozaar
PlaceboDrug

Study groups in NCT02263729
Study group	Role	What they receive
Losartan	Active comparator	Subjects will taken 50mg of losartan per day for 4 weeks Receives: Drug: Losartan
Placebo	Placebo comparator	Subjects will be given placebo to replicate appearance of losartan pills. Placebo pill will be taken once per day. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Reported Effects of Losartan for Hamstring Injury for Safety and Tolerability
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.
Measured: 4 weeks
Recovery of Hamstring Muscle Function
For specific aim 2, hamstring muscle function of the injured leg was measured and compared to the contralateral leg using isometric hamstring force at 30, 60, and 90 degrees of knee flexion at 6 weeks and 6 months.
Data are expressed as a Limb Symmetry Index (LSI), which is the percent force of the injured hamstring compared to the force of the non-injured hamstring muscle.
Measured: 6 weeks; 6 months
Recovery of Hamstring Structure
For specific aim 2, recovery of hamstring structure was measured as the length of injury at 6 months as well as the change in proximal-distal length of injury from baseline to 6 month post-treatment MRI. Greater change in length represents greater healing.
Measured: 6 months
Recovery of Hamstring Structure
For specific aim 2, hamstring structure was measured in terms of the volume of fibrosis at 6 month MRI, as such smaller volume of fibrosis represents greater healing of the hamstring muscle. Hamstring structure was also determined by comparing the change of pre-treatment volume of the injury on the baseline MRI to the volume of fibrosis on the 6 month MRI.
Measured: 6 months
Return to Prior Level of Function
Return to prior level of function will be measured by the number of days from injury to full, unrestricted return to practice. This could have occurred at any timepoint after 6 weeks, so this did not necessarily occur at 12 months but it was monitored until the 12 month timepoint.
Measured: 12 months
Recurrence of Injury
Number of recurrent injuries will be monitored during the duration of the subjects participation.
Measured: 12 months

Secondary outcomes (8)

Recovery of Hamstring Structure
For specific aim 2, restoration of hamstring structure was operationally defined as the ratio of the volume of the injured to contralateral leg hamstring volume 6 months after injury 6 months post-injury. The percent of hamstring volume of the injured leg was expressed as a percentage of the hamstring volume of the contralateral normal leg. The difference in volume between the involved and non-involved hamstring muscles was divided by the non-involved hamstring muscle volume and multiplied by 100.
Measured: 6 months
Return to Prior Level of Function
For specific aims 3 and 4, return to prior level of sports activity was measured by the Marx Activity Scale Score, which ranges from 0 to 16, with 16 being the highest level of sports activity. The frequency of participants who achieved the same or better Marx score at follow-up compared to baseline was calculated. Differences from baseline to each follow-up timepoint were calculated by subtracting the follow-up scores from baseline. Any difference of 0 or a negative number indicated the participants achieved the same level of sports activity or better. Positive differences indicated they did not return to their prior level of sports activity.
Measured: 4 Weeks, 6 Weeks, 3 Months, 4 Months, 6 Months, 12 Months
Recovery of Hamstring Flexibility
For specific aim 2, hamstring muscle flexibility of the injured leg was measured and compared to the contralateral leg using the popliteal angle at 6 weeks and 6 months after randomization. The popliteal angle was measured with a goniometer. Recovery of hamstring flexibility was operationally defined as the difference in the popliteal angle between the contralateral normal leg minus the hamstring injured leg. Positive differences between the contralateral and injured leg indicated decreased hamstring flexibility.
Measured: 6 weeks; 6 months
Recovery of Hamstring Muscle Function
For specific aim 2, hamstring muscle function of the injured leg was measured and compared to the contralateral leg using isometric hamstring force at 1 week, 2 weeks, 3 weeks, and 4 weeks. Data were expressed as a Limb Symmetry Index (LSI), which is the percent strength of the injured hamstring in comparison to the strength of the non-injured hamstring muscle.
Measured: 1 week; 2 weeks; 3 week; 4 weeks
Recovery of Hamstring Muscle Function
For specific aim 2, hamstring muscle function of the injured leg was measured on the Biodex and compared to the contralateral leg using isokinetic peak torque at 60 degrees and 180 degrees per second at 6 weeks and 6 months. Data were expressed as a Limb Symmetry Index (LSI), which is the percent peak torque of the injured hamstring compared to the peak torque of the non-injured hamstring muscle.
The isokinetic testing was not consistently collected, so there are limited results to present at 6 months.
Measured: 6 weeks, 6 months
Recovery of Hamstring Muscle Function
For specific aim 2, hamstring muscle function of the injured leg was measured on the Biodex and compared to the contralateral leg using isokinetic total hamstring work at 60 degrees per second and 180 degrees per second at 6 weeks and 6 months. Data were expressed as a Limb Symmetry Index (LSI), which is the percent total work of the injured hamstring compared to the total work of the non-injured hamstring muscle.
The isokinetic testing was not consistently collected, so there are limited results to present at 6 months.
Measured: 6 weeks, 6 months
Recovery of Hamstring Muscle Function
For specific aim 2, the ratio of hamstring peak torque to quadriceps peak torque at 60 degrees per second of the injured and non-injured legs were measured on the Biodex at 6 weeks.
The isokinetic testing was not consistently collected, so there are limited results to present at 6 months.
Measured: 6 weeks, 6 months
Recovery of Hamstring Muscle Function
For specific aim 2, the ratio of hamstring work in the last 3 repetitions to work in the first 3 repetitions at 180 degrees per second of the injured leg was measured on the Biodex at 6 weeks.
The isokinetic testing was not consistently collected, so there are no results to present at 6 months.
Measured: 6 weeks, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 201631 Dec 2022

First posted13 Oct 2014 (estimated)
Study start10 Aug 2016
Primary completion31 Dec 2022
Study completion31 Dec 2022

Why it stopped: The study was terminated due to difficulty identifying eligible participants and the expiration of funding.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hamstring InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02263729
Sponsor's protocol ID: STUDY19100320
Other IDs: W81XWH-14-2-0003
Status last verified: Apr 2024
First submitted: 26 Sep 2014
Last updated: 2 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
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Hamstring Injuries, Hamstring Muscle Repair
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Recruiting
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
ACL - Anterior Cruciate Ligament Rupture
RecruitingObservational study
Neuromuscular Profiles After Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injury
Recruiting
Effects Of Criteria Versus Time-Based Rehabilitation On Return To Play In Football Players
Hamstring Muscle Strain

All Hamstring Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1/2 Prospective Double-blind, Placebo-controlled Randomized Clinical Trial Using Losartan to Treat Grade II and III Hamstring Strains
ClinicalTrials.gov ID: NCT02263729
Acronym / sponsor ID: STUDY19100320
Conditions: Hamstring Injury
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated due to difficulty identifying eligible participants and the expiration of funding.
Enrolment: 8 participants (actual)
Lead sponsor: James J. IrrgangUniversity, hospital or other
Collaborators: Brooke Army Medical Center, Wake Forest University
Study start: 10 Aug 2016 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 13 Oct 2014 (estimated)
Results: Posted 2 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Losartan	Active comparator	Drug: LosartanSubjects will taken 50mg of losartan per day for 4 weeks
Placebo	Placebo comparator	Drug: PlaceboSubjects will be given placebo to replicate appearance of losartan pills. Placebo pill will be taken once per day.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (19 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LosartanCozaar	Drug	Losartan
Placebo	Drug	Placebo

Primary outcome

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
Time frame: 6 weeks; 6 months
For specific aim 2, hamstring muscle function of the injured leg was measured and compared to the contralateral leg using isometric hamstring force at 30, 60, and 90 degrees of knee flexion at 6 weeks and 6 months. Data are expressed as a Limb Symmetry Index (LSI), which is the percent force of the injured hamstring compared to the force of the non-injured hamstring muscle.
Recovery of Hamstring Structure
Time frame: 6 months
For specific aim 2, recovery of hamstring structure was measured as the length of injury at 6 months as well as the change in proximal-distal length of injury from baseline to 6 month post-treatment MRI. Greater change in length represents greater healing.
Recovery of Hamstring Structure
Time frame: 6 months
For specific aim 2, hamstring structure was measured in terms of the volume of fibrosis at 6 month MRI, as such smaller volume of fibrosis represents greater healing of the hamstring muscle. Hamstring structure was also determined by comparing the change of pre-treatment volume of the injury on the baseline MRI to the volume of fibrosis on the 6 month MRI.
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. This could have occurred at any timepoint after 6 weeks, so this did not necessarily occur at 12 months but it was monitored until the 12 month timepoint.
Recurrence of Injury
Time frame: 12 months
Number of recurrent injuries will be monitored during the duration of the subjects participation.

8 secondary outcomes

Recovery of Hamstring Structure
Time frame: 6 months
Return to Prior Level of Function
Time frame: 4 Weeks, 6 Weeks, 3 Months, 4 Months, 6 Months, 12 Months
Recovery of Hamstring Flexibility
Time frame: 6 weeks; 6 months
Recovery of Hamstring Muscle Function
Time frame: 1 week; 2 weeks; 3 week; 4 weeks
Recovery of Hamstring Muscle Function
Time frame: 6 weeks, 6 months
Recovery of Hamstring Muscle Function
Time frame: 6 weeks, 6 months
Recovery of Hamstring Muscle Function
Time frame: 6 weeks, 6 months
Recovery of Hamstring Muscle Function
Time frame: 6 weeks, 6 months

Results and safety

Results posted to the registry on 2 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Losartan	3	2
Placebo	3	2

Primary outcome: Reported Effects of Losartan for Hamstring Injury for Safety and Tolerability

Time frame: 4 weeks. Count of participants. Unit: Participants

Measure	Losartan n = 3	Placebo n = 3
Hypotension	0	0
Serious adverse events	0	0
Drug related adverse event	0	0
Side effects	0	0
Abnormal labs	0	0
No adverse events, serious adverse events, and patient reported side effects.	3	3

Primary outcome: Recovery of Hamstring Muscle Function

Time frame: 6 weeks; 6 months. Mean (95% Confidence Interval). Unit: % of contralateral limb strength

Measure	Losartan n = 3	Placebo n = 3
6 weeks: Limb Symmetry Index isometric strength at 30 deg knee flexion (Handheld dynamometer)	91 (42 to 139)	75 (21 to 129)
6 weeks: Limb Symmetry Index isometric strength at 90 deg knee flexion (Handheld dynamometer)	102 (67 to 137)	77 (69 to 85)
6 weeks: Limb Symmetry Index isometric strength at 60 deg knee flexion (Biodex)	79 (59 to 98)	73 (15 to 130)
6 months: Limb Symmetry Index isometric strength at 30 deg knee flexion (Handheld dynamometer)	107 (0 to 323)	95 (0 to 355)
6 months: Limb Symmetry Index isometric strength at 90 deg knee flexion (Handheld dynamometer)	106 (0 to 290)	76 (0 to 590)
6 months: Limb Symmetry Index isometric strength at 60 deg knee flexion (%, Biodex)	83 (45 to 121)	104

Population analysed: Losartan Group: 4 wk data at 30 \& 90 degrees substituted for 6 wk data (1 subject lost to follow-up at 4 wks, 1 data not collected). 6 wk data at 60 degrees missing for subject lost to follow-up at 4 wks. 6 m data missing for subject lost to follow-up at 4 wks \& not collected for 1 subject Placebo group: 6 wk data at 60 degrees not collected for 1 participant. 6 m data missing for 1 subject that moved out of the area prior to 6 m \& data not collected for 1 subject at 60 degrees of flexion

Primary outcome: Recovery of Hamstring Structure

Time frame: 6 months. Mean (95% Confidence Interval). Unit: centimeters

Measure	Losartan n = 1	Placebo n = 2
Proximal-distal length of injury measured (MRI)	0.8	5.6 (0 to 67)
Change in proximal-distal length of injury from baseline (MRI)	23	17.6 (0 to 140)

Population analysed: Losartan group: one participant was completely lost to follow-up after 4 weeks. There is also missing MRI data for 6-month timepoint for one other participant. Placebo group: one participant moved out of the area before the 6-month visit and did not complete the 6 month clinical research visit.

Primary outcome: Recovery of Hamstring Structure

Time frame: 6 months. Mean (95% Confidence Interval). Unit: cubic centimeters

Measure	Losartan n = 1	Placebo n = 2
Volume of fibrosis at 6 months (MRI)	0.6	0.7 (0 to 3)
Change of pre-treatment volume of the injury to 6 months (MRI)	138.4	1028 (0 to 10691)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Losartan	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Placebo	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3

Limitations and caveats (from the sponsor): Recruitment was complicated primarily due to delays in identifying potential study participants, as individuals were often excluded for presenting \> 7 days from injury (n=106), not having at least a grade 2 injury (n=9), or refusing participation (n=9). The study was terminated due to the expiration of funding, which resulted in a sample size of 6 participants. Given this sample size was smaller than anticipated, no between-group significance testing was performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hamstring Injury

Recruiting
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Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Recruiting
Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

James J Irrgang, PT, PhD principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Losartan in people with Hamstring Injury, run by James J. Irrgang at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reported Effects of Losartan for Hamstring Injury for Safety and Tolerability (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02263729.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.