Oxandrolone Pill for Rotator Cuff Tears

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Rotator Cuff TearsOxandrolone Pill - Drug
Eligibility
40 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a medication to see if it helps healing and restoring muscle mass after a rotator cuff repair.

Eligible Conditions
  • Rotator Cuff Tears

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks

Week 104
change in structural integrity of the rotator cuff/tendon healing
Week 104
change in ASES shoulder score
change in Body Composition
change in Functional Outcome - Shoulder Strength
change in PASS Score
change in VAS pain scale

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Treatment Group
1 of 2
Placebo Group
1 of 2

Experimental Treatment

Non-Treatment Group

144 Total Participants · 2 Treatment Groups

Primary Treatment: Oxandrolone Pill · Has Placebo Group · Phase 2

Treatment Group
Drug
Experimental Group · 1 Intervention: Oxandrolone Pill · Intervention Types: Drug
Placebo Group
Drug
PlaceboComparator Group · 1 Intervention: Placebo Oral Tablet · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
827 Previous Clinical Trials
1,419,870 Total Patients Enrolled
George R Hatch, MDPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
12 Total Patients Enrolled

Eligibility Criteria

Age 40 - 75 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a full thickness rotator cuff tear on MRI.
References