OsteoarthritisPhase 1/2NCT04589611
Translating Metabolic Responses to Mechanical Insult Into Early Interventions to Prevent PTOA
A Phase 1/2 study testing amobarbital/Gel-One (one dose) and amobarbital/Gel-One (two doses) in people with Osteoarthritis and Post-traumatic Osteoarthritis, run by J L Marsh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteoarthritis, Post-traumatic Osteoarthritis
- What is being tested?
- amobarbital/Gel-One (one dose) and amobarbital/Gel-One (two doses)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2022to 1 May 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- 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
- Posterior malleolar and supination adduction rotational fractures that have an articular fracture line across the articular surface of the distal tibia. Posterior malleolar fractures should affect 25% of the articular surface or greater.
- Fractures must have initial treatment within 72 hours of injury including initial injection of amobarbital or placebo.
Who cannot join
- Diabetes
- Pregnant or nursing mothers and individuals with child-bearing potential that are not using birth control methods with >99% efficacy.
- Allergy to poultry products or cinnamon
- Previous injuries to the ankle
- High grade open wounds
- Pre-existing immunologic or hematologic diseases
Show all 11Show fewer
- Pre-existing ankle arthritis
- Ipsilateral fractures
- Associated injuries that preclude standard rehabilitation
- Pre-existing dysfunction of the kidneys, liver, blood, immune system, endocrine system (excluding diabetes)
- Serum creatinine >/= 1.4 mg/dl; BUN > 30 mg/dl; ALT >/= 60 IU/L in males and >/= 50 IU/L in females; AST >/= 45 IU/L in males and > 40 IU/L in females; bilirubin > 1.3 mg/dL; platelets </= 50,000/ul; glucose > 200 mg/dL
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
Phase I:6 subjects will be treated with a single dose open label, and safety measures will be assessed.
Phase II: Once initial safety is confirmed, 20 amobarbital:10 control subjects will be treated with the single dose at the initial operation.
Assuming continued safety, an additional 20 amobarbital:10 control subjects will be treated with two doses and evaluated. The second dose of 2.5 mM amobarbital will be administered during the second operation.
Subjects will participate in the following procedures:
SOC surgical intervention Randomization to Amobarbital/Gel-One arm or control arm X-rays CT scans Blood and urine Questionnaires
- Conditions
- Osteoarthritis, Post-traumatic Osteoarthritis
- Being tested
- amobarbital/Gel-One (one dose), Placebo (single dose), amobarbital/Gel-One (two doses), Placebo (two doses)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amobarbital/Gel-One (one dose)Drug
One dose of amobarbital/Gel-One during the initial surgical intervention
Placebo (single dose)Drug
One dose of placebo during the initial surgical intervention
amobarbital/Gel-One (two doses)Drug
One dose of amobarbital/Gel-One during the initial surgical intervention. A second dose will be administered during the second surgical intervention.
Placebo (two doses)Drug
One dose of placebo during the initial surgical intervention. A second dose will be administered during the second surgical intervention.
| Study group | Role | What they receive |
|---|---|---|
| Phase I single amobarbital/Gel-One dose | Experimental | 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. Receives: Drug: amobarbital/Gel-One (one dose) |
| Phase IIa Part 1 amobarbital/Gel-One dose | Active comparator | 20 subjects will be randomized to amobarbital/Gel-One single dose. Receives: Drug: amobarbital/Gel-One (one dose) |
| Phase IIa Part 1 Placebo | Placebo comparator | 10 subjects will be randomized to amobarbital/Gel-One single dose. Receives: Drug: Placebo (single dose) |
| Phase IIa Part 2 amobarbital/Gel-One dose | Active comparator | 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. Receives: Drug: amobarbital/Gel-One (two doses) |
| Phase IIa Part 2 placebo | Placebo comparator | 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. Receives: Drug: Placebo (two doses) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Systemic Adverse Events Defined as Abnormal Laboratory Values and Number Where Amobarbital is Detected Systemically
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.
Measured: 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. At the time of internal fixation (3-21 days after external fixation) and at 1, 2, and 4 days post-op.]
Determine the Number of Participants With a Change of Local Toxicity in Tissues. (Outcome Discontinued)
Local toxicity will be determined by examining the osteochondral fragments obtained during the internal fixation surgery for cartilage and synovial histological changes.
This outcome was discontinued. Samples were not taken and this measurement was not completed.
Measured: 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. At the time of internal fixation (3-21 days after external fixation) and at 1, 2, and 4 days post-op.
Secondary outcomes (8)
Patient Reported Outcome Measurement Information Systems (PROMIS) - Pain Interference
Pain Interference scale. Higher scores indicate greater pain interference (worse score). Result is reported as a T-score, with the population norm at 50 and a standard deviation of 10.
Measured: 3, 6, 12, and 24 months
Patient Reported Outcome Measurement Information Systems (PROMIS) Physical Function
Physical Function - T-score - mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. Higher is better.
Measured: 3, 6, 12 and 24 month follow-up visit
Patient Reported Outcome Measurement Information Systems (PROMIS) Global Health Questionnaires - Mental Health and Physical Health Scores
Global Health - T-score - mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. Higher is better.
Measured: 6, 12 and 24 month follow-up
American Orthopaedic Foot and Ankle Society (AOFAS) Score.
0-100 point scale with 100 perfect ankle function
Measured: 6,12 and 24 month follow-up
Foot and Ankle Disability Index (FADI). ADL and Sports Scores
Description: Results are reported on a percentage scale with 100% perfect (higher is better)
Measured: 6, 12 and 24 month follow-up
CT-based Fracture Energy
Fracture energy is measured in Joules. It is from CT data and measured computationally. It is a continuous measure - Higher Joules = more energy = worse fracture
Measured: calculated at 6 month follow-up
CT-based Contact Stress
Vertical CT scan of ankle are segmented and analyzed using finite element analysis. Results are expressed as Contract Stress Exposure (MPa) across areas.
Scans were completed in 4 participants at baseline, 4 participants at 6 month visit, 1 participant at month 12 and 1 participant at month 24.
Contact stress measurements were not completed on any scans and are not avaialble.
Measured: 6, 12 and 24 month follow-up
CT-based Joint Space Width
Vertical CT scan of ankle used to measure Joint Space Width at several locations to measure distance to calculate the mean tibiotalar joint space (mm).
Measured: Month 0, 6, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start20 Jul 2022
- Primary completion1 Dec 2023
- Study completion1 May 2025
Why it stopped: Phase I portion was completed. Phase II will now be completed at a different institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Phase I: 6 patients will be treated with single dose open label, and safety measures will be assessed. Phase IIa: Once initial safety is confirmed, 20 amobarbital:10 control patients will be treated with the single dose at the initial operation. Patients and attending surgeons will be blinded to the identity of the dose. Assuming continued safety, an additional 20 amobarbital: 10 control patients will be treated with two doses and evaluated. The second dose of 2.5 mM amobarbital will be administered during the second operation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- J L Marsh
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, J L Marsh, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589611
- Sponsor's protocol ID
- 201911366
- Status last verified
- Sep 2025
- First submitted
- 23 Jun 2020
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified radiographic and clinical data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Metabolic Responses to Mechanical Insult Into Early Interventions to Prevent PTOA
- ClinicalTrials.gov ID
- NCT04589611
- Acronym / sponsor ID
- 201911366
- Conditions
- Osteoarthritis, Post-traumatic Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Phase I portion was completed. Phase II will now be completed at a different institution.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- J L MarshUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 6 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Phase I:6 subjects will be treated with a single dose open label, and safety measures will be assessed.
Phase II: Once initial safety is confirmed, 20 amobarbital:10 control subjects will be treated with the single dose at the initial operation.
Assuming continued safety, an additional 20 amobarbital:10 control subjects will be treated with two doses and evaluated. The second dose of 2.5 mM amobarbital will be administered during the second operation.
Subjects will participate in the following procedures:
SOC surgical intervention Randomization to Amobarbital/Gel-One arm or control arm X-rays CT scans Blood and urine Questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
- Model description
- Phase I: 6 patients will be treated with single dose open label, and safety measures will be assessed. Phase IIa: Once initial safety is confirmed, 20 amobarbital:10 control patients will be treated with the single dose at the initial operation. Patients and attending surgeons will be blinded to the identity of the dose. Assuming continued safety, an additional 20 amobarbital: 10 control patients will be treated with two doses and evaluated. The second dose of 2.5 mM amobarbital will be administered during the second operation.
| Arm | Type | Receives |
|---|---|---|
| Phase I single amobarbital/Gel-One dose | Experimental | Drug: amobarbital/Gel-One (one dose)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. |
| Phase IIa Part 1 amobarbital/Gel-One dose | Active comparator | Drug: amobarbital/Gel-One (one dose)20 subjects will be randomized to amobarbital/Gel-One single dose. |
| Phase IIa Part 1 Placebo | Placebo comparator | Drug: Placebo (single dose)10 subjects will be randomized to amobarbital/Gel-One single dose. |
| Phase IIa Part 2 amobarbital/Gel-One dose | Active comparator | Drug: amobarbital/Gel-One (two doses)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. |
| Phase IIa Part 2 placebo | Placebo comparator | Drug: Placebo (two doses)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years
- 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
- Posterior malleolar and supination adduction rotational fractures that have an articular fracture line across the articular surface of the distal tibia. Posterior malleolar fractures should affect 25% of the articular surface or greater.
- Fractures must have initial treatment within 72 hours of injury including initial injection of amobarbital or placebo.
Key exclusion criteria (11 listed)
- Diabetes
- Pregnant or nursing mothers and individuals with child-bearing potential that are not using birth control methods with >99% efficacy.
- Allergy to poultry products or cinnamon
- Previous injuries to the ankle
- High grade open wounds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amobarbital/Gel-One (one dose)One dose of amobarbital/Gel-One during the initial surgical intervention | Drug | Phase I single amobarbital/Gel-One dose, Phase IIa Part 1 amobarbital/Gel-One dose |
| Placebo (single dose)One dose of placebo during the initial surgical intervention | Drug | Phase IIa Part 1 Placebo |
| amobarbital/Gel-One (two doses)One dose of amobarbital/Gel-One during the initial surgical intervention. A second dose will be administered during the second surgical intervention. | Drug | Phase IIa Part 2 amobarbital/Gel-One dose |
| Placebo (two doses)One dose of placebo during the initial surgical intervention. A second dose will be administered during the second surgical intervention. | Drug | Phase IIa Part 2 placebo |
Primary outcome
Number of Participants With Systemic Adverse Events Defined as Abnormal Laboratory Values and Number Where Amobarbital is Detected Systemically
Time frame: 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. At the time of internal fixation (3-21 days after external fixation) and at 1, 2, and 4 days post-op.]
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.
Determine the Number of Participants With a Change of Local Toxicity in Tissues. (Outcome Discontinued)
Time frame: 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. At the time of internal fixation (3-21 days after external fixation) and at 1, 2, and 4 days post-op.
Local toxicity will be determined by examining the osteochondral fragments obtained during the internal fixation surgery for cartilage and synovial histological changes. This outcome was discontinued. Samples were not taken and this measurement was not completed.
8 secondary outcomes
Patient Reported Outcome Measurement Information Systems (PROMIS) - Pain Interference
Time frame: 3, 6, 12, and 24 months
Patient Reported Outcome Measurement Information Systems (PROMIS) Physical Function
Time frame: 3, 6, 12 and 24 month follow-up visit
Patient Reported Outcome Measurement Information Systems (PROMIS) Global Health Questionnaires - Mental Health and Physical Health Scores
Time frame: 6, 12 and 24 month follow-up
American Orthopaedic Foot and Ankle Society (AOFAS) Score.
Time frame: 6,12 and 24 month follow-up
Foot and Ankle Disability Index (FADI). ADL and Sports Scores
Time frame: 6, 12 and 24 month follow-up
CT-based Fracture Energy
Time frame: calculated at 6 month follow-up
CT-based Contact Stress
Time frame: 6, 12 and 24 month follow-up
CT-based Joint Space Width
Time frame: Month 0, 6, 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified radiographic and clinical data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing amobarbital/Gel-One (one dose) and amobarbital/Gel-One (two doses) in people with Osteoarthritis and Post-traumatic Osteoarthritis, run by J L Marsh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Systemic Adverse Events Defined as Abnormal Laboratory Values and Number Where Amobarbital is Detected Systemically (time frame: 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. At the time of internal fixation (3-21 days after external fixation) and at 1, 2, and 4 days post-op.]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.