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
|Condition or disease||Intervention/treatment||Phase|
|Hamstring Injury||Drug: Losartan Drug: placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 :||July 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 31, 2021|
Active Comparator: losartan
Subjects will taken 50mg of losartan per day for 4 weeks
Placebo Comparator: placebo
Subjects will be given placebo to replicate appearance of losartan pills. Placebo pill will be taken once per day.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263729
|Contact: James Irrgang, PT,PhDfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: James Irrgang, PT, PhD email@example.com|
|Principal Investigator: James Irrgang, PT, PhD|