Ankle FracturesPhase 4NCT03696199
Randomized Controlled Trial for Ankle Fracture Pain Control
A Phase 4 study testing Long-Acting Local Anesthesia and Regional Anesthesia in people with Ankle Fractures, run by Lahey Clinic at 1 site in United States.
Trial summary
This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Long-Acting Local Anesthesia and Regional Anesthesia
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sustained a bimalleolar ankle fracture (OTA/AO type 44 A2, B2, C1, and C2 fracture) with surgery indicated and an approach with medial and lateral incisions planned Syndesmotic injuries will be included, due to the practical difficulty of reliably determining the presence of a syndesmotic injury preoperatively Trimalleolar ankle fractures where fixation of the posterior malleolus is not planned will also be included
- Isolated Injury
Who cannot join
- Unifocal malleolar fractures
- Bimalleolar fractures where fixation of only one malleolus is planned
- Posterior malleolus fractures requiring fixation
- Patients ineligible for a peripheral nerve block (e.g. concern for compartment syndrome)
- Open injury
- Patients treated with external fixation
Show all 15Show fewer
- Neurologic condition that would confound results (e.g. peripheral neuropathy)
- Inability to consent
- Chronic opioid use
- History of opiate abuse
- Polytrauma as defined as additional boney injury, visceral injury or moderate soft tissue injury (requiring suture repair or other invasive procedure)
- Prisoners (unlikely to be accessible for follow-up)
- Pregnant patients
- Non-English-speaking subjects (post-operative data collection procedure involves conversations via phone calls. As we do not have access to translators for this research project, we will work exclusively with English-speaking subjects).
- Subjects unable to take the standard post-operative pain regimen that consists of gabapentin, oxycodone, acetaminophen, and ibuprofen.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
Eric Swart, MD, 781-744-2629
About this study
Official title: A Prospective, Randomized Trial Evaluating Regional Anesthesia, Long-Acting Local Anesthesia, and Traditional Care for Pain Control of Operatively Treated Ankle Fractures
This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.
Read the detailed description
This study is a multicenter, three armed, prospective randomized control trial studying the effect of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.
Primary Hypothesis Driven Aims:
- Determine the effectiveness of a local anesthesia "cocktail" compared to regional block or standard of care in controlling pain in operatively treated ankle fractures. Nearly one out of ten fractures treated by both orthopaedic traumatologists and general orthopaedic surgeons taking call are ankle fractures. As such, effective pain control in this group of patients represents an opportunity to make a large impact, especially in the context of the current opioid epidemic. Improved pain control can help improve patient satisfaction, outcomes, decrease length of stay, cost of care, and complications associated with traditional narcotic use.
- Hypothesis 1A: Patients receiving the intraoperative cocktail will have improved post-operative pain control compared to those receiving a peri-operative nerve block or standard of care.
- Hypothesis 1B: Patients receiving the intraoperative cocktail or peri-operative nerve block will have improved post-operative pain control when compared to standard of care.
- Null Hypothesis 1: There will be no difference in post-operative pain control between all treatment arms.
- Determine the economic impact of cocktail and regional blocks in ankle fractures. A common concern with the use of regional blocks is the cost of the additional procedure, along with logistic delays which are associated with coordinating a separate procedure. This study would provide valuable data about the additional costs associated with regional blocks and with cocktail administration which could help aid in making economically conscious treatment decisions.
- Hypothesis 2: Local cocktail administration will have significantly lower costs than regional block, and not be significantly more expensive than standard of care.
- Null Hypothesis 2: There is no difference in cost between the modalities.
Secondary Aim:
Demonstrate the use of long-acting local anesthetic as a viable pain management strategy in fracture surgery. Although long-acting local anesthetics have an established track record in arthroplasty, there is a paucity of evidence guiding their use in fractures. Small case series in trauma and foot/ankle patients have been encouraging, but a rigorously conducted, prospective trial in a relatively homogeneous group could generate pilot data to validate the use of long acting local anesthetics in fracture surgery. This knowledge may be translatable to other extremity injuries as well, having a greater impact than the scope of the proposed trial.
- Conditions
- Ankle Fractures
- Being tested
- Long-Acting Local Anesthesia, Regional Anesthesia
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-Acting Local AnesthesiaDrug
Also called Local Cocktail
The cocktail consists of:
- 0.5% Ropivicaine, 24.6 mL
- Clonidine 100 mcg/mL, 0.4mL
- Epinephrine 1mg/mL, 0.5mL
- Saline to total volume of 50 mL (24.5mL of saline)
The total amount of solution prepared is 50mL, but typically 30mL is used based on the size of the incision. The total volume administered will be recorded.
Regional AnesthesiaDrug
Also called Ropivicaine
0.5% ropivicaine - 30mL each sciatic and femoral/saphenous nerve, ultrasound guided
| Study group | Role | What they receive |
|---|---|---|
| Traditional Pain Control Care | No intervention | Standard of care post-operative pain control with oral narcotics |
| Regional Anesthesia | Experimental | Single injection perioperative peripheral nerve block + followed by administration of oral narcotics on a need-based system Receives: Drug: Regional Anesthesia |
| Long-Acting Local Anesthesia | Experimental | Subcutaneous local cocktail injection + followed by administration of oral narcotics on a need-based system Receives: Drug: Long-Acting Local Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Narcotics / Morphine Milligram Equivalents (MME) given
The medical record (EPIC) will be used to determine the total morphine equivalents given to the patient post-surgery, including recovery unit administration of narcotics in the immediate post-operative period.
Measured: 72 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start1 Sep 2020
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Ankle FracturesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Francis Swart, Lahey Clinic
- Investigators
- Eric Swart, MD, Principal investigator, Lahey Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696199
- Sponsor's protocol ID
- 20223040
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2018
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Barrington JW, Olugbode O, Lovald S, Ong K, Watson H, Emerson RH Jr. Liposomal Bupivacaine: A Comparative Study of More Than 1000 Total Joint Arthroplasty Cases. Orthop Clin North Am. 2015 Oct;46(4):469-77. doi: 10.1016/j.ocl.2015.06.003. Epub 2015 Aug 6.
PubMed 26410636Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.
PubMed 22285545Ng FY, Ng JK, Chiu KY, Yan CH, Chan CW. Multimodal periarticular injection vs continuous femoral nerve block after total knee arthroplasty: a prospective, crossover, randomized clinical trial. J Arthroplasty. 2012 Jun;27(6):1234-8. doi: 10.1016/j.arth.2011.12.021. Epub 2012 Feb 8.
PubMed 22325963Lonner J. Role of liposomal bupivacaine in pain management after total joint arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):37-41. doi: 10.3113/jsoa.2014.0037.
PubMed 24641895Hutchinson HL. Local infiltration of liposome bupivacaine in orthopedic trauma patients: case-based reviews. Am J Orthop (Belle Mead NJ). 2014 Oct;43(10 Suppl):S13-6.
PubMed 25303455Herbst SA. Local infiltration of liposome bupivacaine in foot and ankle surgery: case-based reviews. Am J Orthop (Belle Mead NJ). 2014 Oct;43(10 Suppl):S10-2.
PubMed 25303454Stein BE, Srikumaran U, Tan EW, Freehill MT, Wilckens JH. Lower-extremity peripheral nerve blocks in the perioperative pain management of orthopaedic patients: AAOS exhibit selection. J Bone Joint Surg Am. 2012 Nov 21;94(22):e167. doi: 10.2106/JBJS.K.01706.
PubMed 23172334Wang J, Liu GT, Mayo HG, Joshi GP. Pain Management for Elective Foot and Ankle Surgery: A Systematic Review of Randomized Controlled Trials. J Foot Ankle Surg. 2015 Jul-Aug;54(4):625-35. doi: 10.1053/j.jfas.2014.05.003. Epub 2014 Jun 18.
PubMed 24954920Compton P, Athanasos P. Chronic pain, substance abuse and addiction. Nurs Clin North Am. 2003 Sep;38(3):525-37. doi: 10.1016/s0029-6465(02)00100-7.
PubMed 14567207De Maeyer J, Vanderplasschen W, Broekaert E. Quality of life among opiate-dependent individuals: A review of the literature. Int J Drug Policy. 2010 Sep;21(5):364-80. doi: 10.1016/j.drugpo.2010.01.010. Epub 2010 Feb 20.
PubMed 20172706Morrone LA, Scuteri D, Rombola L, Mizoguchi H, Bagetta G. Opioids Resistance in Chronic Pain Management. Curr Neuropharmacol. 2017 Apr;15(3):444-456. doi: 10.2174/1570159X14666161101092822.
PubMed 28503117Holman JE, Stoddard GJ, Higgins TF. Rates of prescription opiate use before and after injury in patients with orthopaedic trauma and the risk factors for prolonged opiate use. J Bone Joint Surg Am. 2013 Jun 19;95(12):1075-80. doi: 10.2106/JBJS.L.00619.
PubMed 23783203Manchikanti L. National drug control policy and prescription drug abuse: facts and fallacies. Pain Physician. 2007 May;10(3):399-424.
PubMed 17525776Elkassabany N, Cai LF, Mehta S, Ahn J, Pieczynski L, Polomano RC, Picon S, Hogg R, Liu J. Does Regional Anesthesia Improve the Quality of Postoperative Pain Management and the Quality of Recovery in Patients Undergoing Operative Repair of Tibia and Ankle Fractures? J Orthop Trauma. 2015 Sep;29(9):404-9. doi: 10.1097/BOT.0000000000000344.
PubMed 25882965Cometa MA, Esch AT, Boezaart AP. Did continuous femoral and sciatic nerve block obscure the diagnosis or delay the treatment of acute lower leg compartment syndrome? A case report. Pain Med. 2011 May;12(5):823-8. doi: 10.1111/j.1526-4637.2011.01109.x.
PubMed 21564511
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial Evaluating Regional Anesthesia, Long-Acting Local Anesthesia, and Traditional Care for Pain Control of Operatively Treated Ankle Fractures
- ClinicalTrials.gov ID
- NCT03696199
- Acronym / sponsor ID
- 20223040
- Conditions
- Ankle Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.
Detailed description
This study is a multicenter, three armed, prospective randomized control trial studying the effect of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.
Primary Hypothesis Driven Aims:
- Determine the effectiveness of a local anesthesia "cocktail" compared to regional block or standard of care in controlling pain in operatively treated ankle fractures. Nearly one out of ten fractures treated by both orthopaedic traumatologists and general orthopaedic surgeons taking call are ankle fractures. As such, effective pain control in this group of patients represents an opportunity to make a large impact, especially in the context of the current opioid epidemic. Improved pain control can help improve patient satisfaction, outcomes, decrease length of stay, cost of care, and complications associated with traditional narcotic use.
- Hypothesis 1A: Patients receiving the intraoperative cocktail will have improved post-operative pain control compared to those receiving a peri-operative nerve block or standard of care.
- Hypothesis 1B: Patients receiving the intraoperative cocktail or peri-operative nerve block will have improved post-operative pain control when compared to standard of care.
- Null Hypothesis 1: There will be no difference in post-operative pain control between all treatment arms.
- Determine the economic impact of cocktail and regional blocks in ankle fractures. A common concern with the use of regional blocks is the cost of the additional procedure, along with logistic delays which are associated with coordinating a separate procedure. This study would provide valuable data about the additional costs associated with regional blocks and with cocktail administration which could help aid in making economically conscious treatment decisions.
- Hypothesis 2: Local cocktail administration will have significantly lower costs than regional block, and not be significantly more expensive than standard of care.
- Null Hypothesis 2: There is no difference in cost between the modalities.
Secondary Aim:
Demonstrate the use of long-acting local anesthetic as a viable pain management strategy in fracture surgery. Although long-acting local anesthetics have an established track record in arthroplasty, there is a paucity of evidence guiding their use in fractures. Small case series in trauma and foot/ankle patients have been encouraging, but a rigorously conducted, prospective trial in a relatively homogeneous group could generate pilot data to validate the use of long acting local anesthetics in fracture surgery. This knowledge may be translatable to other extremity injuries as well, having a greater impact than the scope of the proposed trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional Pain Control Care | No intervention | –Standard of care post-operative pain control with oral narcotics |
| Regional Anesthesia | Experimental | Drug: Regional AnesthesiaSingle injection perioperative peripheral nerve block + followed by administration of oral narcotics on a need-based system |
| Long-Acting Local Anesthesia | Experimental | Drug: Long-Acting Local AnesthesiaSubcutaneous local cocktail injection + followed by administration of oral narcotics on a need-based system |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sustained a bimalleolar ankle fracture (OTA/AO type 44 A2, B2, C1, and C2 fracture) with surgery indicated and an approach with medial and lateral incisions planned Syndesmotic injuries will be included, due to the practical difficulty of reliably determining the presence of a syndesmotic injury preoperatively Trimalleolar ankle fractures where fixation of the posterior malleolus is not planned will also be included
- Isolated Injury
Key exclusion criteria (15 listed)
- Unifocal malleolar fractures
- Bimalleolar fractures where fixation of only one malleolus is planned
- Posterior malleolus fractures requiring fixation
- Patients ineligible for a peripheral nerve block (e.g. concern for compartment syndrome)
- Open injury
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 |
|---|---|---|
| Long-Acting Local AnesthesiaAlso: Local CocktailThe cocktail consists of: * 0.5% Ropivicaine, 24.6 mL * Clonidine 100 mcg/mL, 0.4mL * Epinephrine 1mg/mL, 0.5mL * Saline to total volume of 50 mL (24.5mL of saline) The total amount of solution prepared is 50mL, but typically 30mL is used based on the size of the incision. The total volume administered will be recorded. | Drug | Long-Acting Local Anesthesia |
| Regional AnesthesiaAlso: Ropivicaine0.5% ropivicaine - 30mL each sciatic and femoral/saphenous nerve, ultrasound guided | Drug | Regional Anesthesia |
Primary outcome
Oral Narcotics / Morphine Milligram Equivalents (MME) given
Time frame: 72 postoperative hours
The medical record (EPIC) will be used to determine the total morphine equivalents given to the patient post-surgery, including recovery unit administration of narcotics in the immediate post-operative period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 26410636Barrington JW, Olugbode O, Lovald S, Ong K, Watson H, Emerson RH Jr. Liposomal Bupivacaine: A Comparative Study of More Than 1000 Total Joint Arthroplasty Cases. Orthop Clin North Am. 2015 Oct;46(4):469-77. doi: 10.1016/j.ocl.2015.06.003. Epub 2015 Aug 6.
- Background: PubMed 22285545Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.
- Background: PubMed 22325963Ng FY, Ng JK, Chiu KY, Yan CH, Chan CW. Multimodal periarticular injection vs continuous femoral nerve block after total knee arthroplasty: a prospective, crossover, randomized clinical trial. J Arthroplasty. 2012 Jun;27(6):1234-8. doi: 10.1016/j.arth.2011.12.021. Epub 2012 Feb 8.
- Background: PubMed 24641895Lonner J. Role of liposomal bupivacaine in pain management after total joint arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):37-41. doi: 10.3113/jsoa.2014.0037.
- Background: PubMed 25303455Hutchinson HL. Local infiltration of liposome bupivacaine in orthopedic trauma patients: case-based reviews. Am J Orthop (Belle Mead NJ). 2014 Oct;43(10 Suppl):S13-6.
- Background: PubMed 25303454Herbst SA. Local infiltration of liposome bupivacaine in foot and ankle surgery: case-based reviews. Am J Orthop (Belle Mead NJ). 2014 Oct;43(10 Suppl):S10-2.
- Background: PubMed 23172334Stein BE, Srikumaran U, Tan EW, Freehill MT, Wilckens JH. Lower-extremity peripheral nerve blocks in the perioperative pain management of orthopaedic patients: AAOS exhibit selection. J Bone Joint Surg Am. 2012 Nov 21;94(22):e167. doi: 10.2106/JBJS.K.01706.
- Background: PubMed 24954920Wang J, Liu GT, Mayo HG, Joshi GP. Pain Management for Elective Foot and Ankle Surgery: A Systematic Review of Randomized Controlled Trials. J Foot Ankle Surg. 2015 Jul-Aug;54(4):625-35. doi: 10.1053/j.jfas.2014.05.003. Epub 2014 Jun 18.
- Background: PubMed 14567207Compton P, Athanasos P. Chronic pain, substance abuse and addiction. Nurs Clin North Am. 2003 Sep;38(3):525-37. doi: 10.1016/s0029-6465(02)00100-7.
- Background: PubMed 20172706De Maeyer J, Vanderplasschen W, Broekaert E. Quality of life among opiate-dependent individuals: A review of the literature. Int J Drug Policy. 2010 Sep;21(5):364-80. doi: 10.1016/j.drugpo.2010.01.010. Epub 2010 Feb 20.
- Background: PubMed 28503117Morrone LA, Scuteri D, Rombola L, Mizoguchi H, Bagetta G. Opioids Resistance in Chronic Pain Management. Curr Neuropharmacol. 2017 Apr;15(3):444-456. doi: 10.2174/1570159X14666161101092822.
- Background: PubMed 23783203Holman JE, Stoddard GJ, Higgins TF. Rates of prescription opiate use before and after injury in patients with orthopaedic trauma and the risk factors for prolonged opiate use. J Bone Joint Surg Am. 2013 Jun 19;95(12):1075-80. doi: 10.2106/JBJS.L.00619.
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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.
Eric Swart, MD principal investigator
Lahey Hospital & Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Long-Acting Local Anesthesia and Regional Anesthesia in people with Ankle Fractures, run by Lahey Clinic 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 2 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 8 Oct 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Swart, MD (781-744-2629, eric.f.swart@lahey.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Narcotics / Morphine Milligram Equivalents (MME) given (time frame: 72 postoperative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03696199, which also lists 26 linked publications.
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 8 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.