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NCT02420353 · ClinicalTrials.gov registry record · Phase 2
Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears
A Phase 2 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT02420353 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 20 participants.
The verdict
NCT02420353, a Phase 2 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
Anterior cruciate ligament (ACL) tears are among the most frequent traumatic knee injuries that occur in physically active individuals. Despite advances in minimally invasive surgical reconstruction techniques and aggressive rehabilitation, this atrophy and loss of strength can persist even after patients return to full activity and can place them at considerable risk for re-injury and developing osteoarthritis (OA). The design of new therapeutic interventions to prevent muscle atrophy is needed to advance the care of patients who suffer from ACL injuries. The growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis plays an important role in promoting muscle growth and protecting muscle from atrophy. While GH therapy has shown promise in protecting immobilized muscle from various models of disuse atrophy, it remains unknown whether GH can help to restore strength and protect against the loss in strength that occurs after ACL tear. GH therapy may help to accelerate the safe return to play of patients that suffer ACL tears, and help to prevent the long-term OA and reduction in quality of life that occur after these traumatic knee injuries.
Interventions
- DRUG Placebo
- DRUG Somatropin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02420353
The ClinicalTrials.gov registry entry for NCT02420353 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02420353 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02420353 about?
NCT02420353 is a clinical study titled "Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears". Anterior cruciate ligament (ACL) tears are among the most frequent traumatic knee injuries that occur in physically active individuals. Despite advances in minimally invasive surgical reconstruction techniques and aggressive rehabilitation, this atrophy and loss of strength can persist even after pa...
What is the current status of trial NCT02420353?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2015-05. Estimated completion is 2018-10.
What interventions are being tested in trial NCT02420353?
The interventions under investigation include: Placebo (DRUG), Somatropin (DRUG).
Who is sponsoring clinical trial NCT02420353?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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