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NCT04572256 · ClinicalTrials.gov registry record · Early Phase 1
MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)
A Early Phase 1 study of ACL Injury and Post-traumatic Osteoarthritis, sponsored by Austin V Stone.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04572256 is a Early Phase 1 study of ACL Injury and Post-traumatic Osteoarthritis that is actively recruiting participants, run by Austin V Stone. The registered enrollment target is 30 participants, below the 502-participant average among 12 other ACL Injury trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04572256, a Early Phase 1 study of ACL Injury and Post-traumatic Osteoarthritis, is actively recruiting participants, sponsored by Austin V Stone.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a multicenter randomized, placebo-controlled trial to assess whether a 6-month course of oral montelukast after ACL reconstruction reduces systemic markers of inflammation and biochemical and imaging biomarkers of cartilage degradation. This study will specifically target older ACL reconstruction patients with concomitant meniscal injuries as this group is at greatest risk of rapid PTOA progression. Patients will randomly be assigned to receive oral montelukast (10 mg) versus placebo daily for 6 months after surgery.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Montelukast
Study Locations (1)
Kentucky
- UK Healthcare at Turfland - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2027-06 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04572256
The ClinicalTrials.gov registry entry for NCT04572256 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 502-participant average among 12 other ACL Injury trials with a reported enrollment target (94% lower). The listed sponsor is Austin V Stone, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with ACL Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04572256 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT04572256 about?
NCT04572256 is a clinical study titled "MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)". This is a multicenter randomized, placebo-controlled trial to assess whether a 6-month course of oral montelukast after ACL reconstruction reduces systemic markers of inflammation and biochemical and imaging biomarkers of cartilage degradation. This study will specifically target older ACL reconstru...
What is the current status of trial NCT04572256?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2021-02-01. Estimated completion is 2027-06.
What conditions does trial NCT04572256 study?
This clinical trial studies the following conditions: ACL Injury, Post-traumatic Osteoarthritis, Meniscus Tear.
What interventions are being tested in trial NCT04572256?
The interventions under investigation include: Placebo (DRUG), Montelukast (DRUG).
Who is sponsoring clinical trial NCT04572256?
This trial is sponsored by Austin V Stone, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04572256 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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