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Barbiturate

Amobarbital/Gel-One for Osteoarthritis

Phase 1 & 2
Recruiting
Research Sponsored by J L Marsh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fractures must have initial treatment within 72 hours of injury including initial injection of amobarbital or placebo.
Acute closed or type 1 open ankle fractures (classified as OTA/AO 43 B 1-3 and 43 C 1- 3 or classified as 42 B and C fractures with 25% talar displacement and one of the following; syndesmosis injury or medial malleolar fracture at or above the shoulder) (Marsh et al., 2007)) without operative ipsilateral extremity trauma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12, and 24 months
Awards & highlights

Study Summary

This trial is testing whether amobarbital can prevent post-traumatic osteoarthritis in people who have fractured their ankle joints. The study is double-blind, meaning that neither the patients nor the researchers will know who is receiving the placebo or the active treatment. 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.

Eligible Conditions
  • Osteoarthritis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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If you have a broken bone, it must be treated within 72 hours of injury with an injection of amobarbital or a placebo.
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You have a certain type of ankle fracture that is not severe enough to require surgery.
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You have a certain type of ankle fracture that involves a break in the bone near the back of the ankle joint and affects a large part of the joint surface.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12, and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the number of participants with a change of local toxicity in tissues.
Determine the number of participants with systemic adverse events including the change in laboratory values to assess the systemic safety of amobarbital.
Secondary outcome measures
American Orthopaedic Foot and Ankle Society (AOFAS) Score.
CT-based Contact Stress
CT-based Joint Space Width
+6 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Phase I single amobarbital/Gel-One doseExperimental Treatment1 Intervention
Phase I: An open label study of 3 patients will be done. If no dose limiting toxic (DLT) side effects occur, then an additional 3 patients will be done. If no DLT events occur, the study will proceed to Phase II.
Group II: Phase IIa Part 2 amobarbital/Gel-One doseActive Control1 Intervention
20 subjects will be randomized to one dose of amobarbital/Gel-One during the initial surgical intervention. A second dose will be administered during the second surgical intervention.
Group III: Phase IIa Part 1 amobarbital/Gel-One doseActive Control1 Intervention
20 subjects will be randomized to amobarbital/Gel-One single dose.
Group IV: Phase IIa Part 1 PlaceboPlacebo Group1 Intervention
10 subjects will be randomized to amobarbital/Gel-One single dose.
Group V: Phase IIa Part 2 placeboPlacebo Group1 Intervention
20 subjects will be randomized to one dose of placebo during the initial surgical intervention. A second dose will be administered during the second surgical intervention.

Find a Location

Who is running the clinical trial?

J L MarshLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
United States Department of DefenseFED
855 Previous Clinical Trials
225,380 Total Patients Enrolled
2 Trials studying Osteoarthritis
150 Patients Enrolled for Osteoarthritis

Media Library

Amobarbital (Barbiturate) Clinical Trial Eligibility Overview. Trial Name: NCT04589611 — Phase 1 & 2
Osteoarthritis Research Study Groups: Phase I single amobarbital/Gel-One dose, Phase IIa Part 1 Placebo, Phase IIa Part 2 amobarbital/Gel-One dose, Phase IIa Part 2 placebo, Phase IIa Part 1 amobarbital/Gel-One dose
Osteoarthritis Clinical Trial 2023: Amobarbital Highlights & Side Effects. Trial Name: NCT04589611 — Phase 1 & 2
Amobarbital (Barbiturate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04589611 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there similar cases to this amobarbital/Gel-One study?

"One clinical trial is ongoing for amobarbital/Gel-One (one dose), which is in Phase 3, with 1 location in Iowa City, Iowa."

Answered by AI

How many study participants can join this trial at most?

"The most recent information available on clinicaltrials.gov says that this study, which was posted on 7/20/2022, is still actively enrolling patients. 66 patients are needed at 1 site."

Answered by AI

What outcomes does this experiment hope to produce?

"The goal of this study is to determine the number of participants with a change in local toxicity in tissues. Secondary objectives include CT-based contact stress and the American Orthopaedic Foot and Ankle Society (AOFAS) score. The study will be measured over a period of Pre-op baseline on the day before external fixation surgery (within 24 hours of injury), immediately post-op, and at 1, 2, and 4 days post-op."

Answered by AI

If an octogenarian meets the other requirements, can they participate in this research project?

"The ideal patient for this clinical trial is someone who is over 18 but younger than 60 years old."

Answered by AI
~25 spots leftby Mar 2025