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NCT04589611 · ClinicalTrials.gov registry record · Phase 1
Translating Metabolic Responses to Mechanical Insult Into Early Interventions to Prevent PTOA
A Phase 1 study of Osteoarthritis and Post-traumatic Osteoarthritis, sponsored by J L Marsh.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT04589611: Completed Phase 1 study of Osteoarthritis and Post-traumatic Osteoarthritis, sponsored by J L Marsh.
NCT04589611 is a Phase 1 study of Osteoarthritis and Post-traumatic Osteoarthritis that has completed, run by J L Marsh. The registered enrollment target is 5 participants, below the 818-participant average among 135 other Osteoarthritis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04589611, a Phase 1 study of Osteoarthritis and Post-traumatic Osteoarthritis, has completed, sponsored by J L Marsh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a small-scale proof-of concept clinical trial of amobarbital as a treatment to prevent post-traumatic osteoarthritis in fractured ankle joints. The study is a double blind, prospective, randomized, placebo-controlled, stepwise trial. Amobarbital will be delivered to ankle joints in solution with hyaluronic acid (HA) as a vehicle. Amobarbital/HA injections (active dose) will be compared to HA alone (placebo dose). Our primary goal is to confirm safety, but we will also assess whether treatment improves chondrocyte viability and decreases synovial inflammation. The intervention that will be utilized has proven to be effective using vitro and in vivo models. The study team will assess safety and begin to evaluate efficacy of amobarbital/Gel-One in patients having sustained tibial pilon fractures. The study team will use advanced imaging-based methods we have developed to characterize how joints subjected to varying levels of fracture severity and residual elevated contact stress respond in treated and control groups.
Primary Outcome
Safety Measures: CBC and standard clinical chemistry assays to quantify circulating, ALT, AST, Bilirubin, Creatinine, and BUN and the measurement of urine protein content will be evaluated and the number of participants with clinically significant abnormal laboratory values will be determined. Presence of amobarbital will be tested in blood and urine samples and the number of subjects it is detected in will be reported.
Conditions Studied
Interventions
- DRUG amobarbital/Gel-One (one dose)
- DRUG Placebo (single dose)
- DRUG amobarbital/Gel-One (two doses)
- DRUG Placebo (two doses)
Study Locations (1)
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2022-07-20 |
| Est. Completion | 2023-12-01 |
| Phase | Phase 1 |
What the finished NCT04589611 record still lists
NCT04589611 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 818-participant average among 135 other Osteoarthritis trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Osteoarthritis appearing as the primary indexed condition, and to 4 interventions - of which amobarbital/Gel-One (one dose) is the first listed.
NCT04589611 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT04589611 about?
NCT04589611 is a clinical study titled "Translating Metabolic Responses to Mechanical Insult Into Early Interventions to Prevent PTOA". This is a small-scale proof-of concept clinical trial of amobarbital as a treatment to prevent post-traumatic osteoarthritis in fractured ankle joints. The study is a double blind, prospective, randomized, placebo-controlled, stepwise trial. Amobarbital will be delivered to ankle joints in solution ...
What is the current status of trial NCT04589611?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2022-07-20. Estimated completion is 2023-12-01.
What conditions does trial NCT04589611 study?
This clinical trial studies the following conditions: Osteoarthritis, Post-traumatic Osteoarthritis.
What interventions are being tested in trial NCT04589611?
The interventions under investigation include: amobarbital/Gel-One (one dose) (DRUG), Placebo (single dose) (DRUG), amobarbital/Gel-One (two doses) (DRUG), Placebo (two doses) (DRUG).
Who is sponsoring clinical trial NCT04589611?
This trial is sponsored by J L Marsh, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04589611 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04589611's enrollment target sits among peer trials
5 136th of 135 the lowest of 135 other Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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