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Barbiturate
Amobarbital/Gel-One for Osteoarthritis
Phase 1 & 2
Waitlist Available
Research Sponsored by J L Marsh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12, and 24 months
Summary
This trial tests a new treatment to prevent arthritis in broken ankle joints. It targets patients with specific types of ankle fractures. The treatment works by protecting the joints and reducing inflammation.
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 12, and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12, and 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
American Orthopaedic Foot and Ankle Society (AOFAS) Score.
CT-based Contact Stress
CT-based Joint Space Width
+6 moreTrial 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
amobarbital/Gel-One (one dose)
2022
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
J L MarshLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Osteoarthritis
20 Patients Enrolled for Osteoarthritis
United States Department of DefenseFED
908 Previous Clinical Trials
333,675 Total Patients Enrolled
2 Trials studying Osteoarthritis
150 Patients Enrolled for Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a broken bone on the same side as the treatment.You have a pre-existing condition that affects your immune system or blood cells.You have arthritis in your ankle before starting the study.If you have a broken bone, it must be treated within 72 hours of injury with an injection of amobarbital or a placebo.You have injuries that prevent you from undergoing normal rehabilitation.You have a pre-existing condition that affects your kidneys, liver, blood, immune system or endocrine system (excluding diabetes).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.You have had an injury to your ankle in the past.You are allergic to chicken or cinnamon.You have severe, open wounds.You have diabetes.You have a certain type of ankle fracture that is not severe enough to require surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I single amobarbital/Gel-One dose
- Group 2: Phase IIa Part 1 Placebo
- Group 3: Phase IIa Part 2 amobarbital/Gel-One dose
- Group 4: Phase IIa Part 2 placebo
- Group 5: Phase IIa Part 1 amobarbital/Gel-One dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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