Pain, PostoperativePhase 4NCT01602692
A Comparison of Tumescence in Breast Reduction Surgery
A Phase 4 study testing Tumescent solution with dilute lidocaine and epinephrine and Tumescent Solution with dilute epinephrine in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The investigators' main hypothesis is that in breast reduction surgery, the use of tumescent solution containing both dilute lidocaine and epinephrine will lead to better control of postoperative pain, nausea, vomiting, shorter time through postoperative phases of care, quicker discharge from the hospital and lower… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Postoperative Nausea and Vomiting
- What is being tested?
- Tumescent solution with dilute lidocaine and epinephrine and Tumescent Solution with dilute epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jul 2014
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients presenting for breast reduction surgery at the University of Wisconsin Hospital and Clinics and the University of Wisconsin Transformations Surgery Center and who do not meet any of the exclusion criteria.
Who cannot join
- Women under the age of 18 years
- Breast feeding or pregnant women
- Incarcerated women.
- Women unable to give consent because of impaired decision making ability.
- Women who have reported allergies to the substances that will be used in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Transformations Surgery Center
Middleton, Wisconsin, 53562
About this study
The investigators' main hypothesis is that in breast reduction surgery, the use of tumescent solution containing both dilute lidocaine and epinephrine will lead to better control of postoperative pain, nausea, vomiting, shorter time through postoperative phases of care, quicker discharge from the hospital and lower numbers of hospital readmissions than the use of tumescent solution containing only dilute epinephrine.
Read the detailed description
Postoperative pain is often undermanaged in surgical patients. In the outpatient surgery population, such as breast reduction surgery, postoperative pain can lead to increased narcotic use, increased nausea, surgical complications and unplanned hospital admission, in addition to patient discomfort or dissatisfaction. Tumescence is a method of infiltrating tissues, such as the breast, with solutions of very dilute lidocaine and/or very dilute epinephrine in order to provide diffuse local anesthesia, hemostasis, and tissue manipulation. Both types of solution are considered standard care and both at the University of Wisconsin, Madison. There are two main aims to this study. Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. Aim 2 of our study is to determine the effect of dilute lidocaine in tumescent solution on secondary post-operative outcomes following breast reduction surgery. The secondary outcomes that will be measured in this study include average time (minutes) spent in the postanesthesia care unit (PACU), average time (minutes) spent in Phase 2, total time (minutes) between the end of case and discharge home, occurrence of unplanned hospital admission, number of episodes of post-operative nausea (subjective feeling vs. emesis) and amount of anti-emetic medication used in pacu, phase 2 and the first 24 hours post-op (mg). The investigators hypothesize that tumescence with lidocaine and epinephrine will have improved post-operative pain control leading to less narcotic use during the first twenty four hours postoperatively. (Aim 1). The investigators also believe that tumescence with lidocaine and epinephrine will lead to less time spent in PACU, less time spent in Phase2, less time between the end of the case and discharge home, less occurrence of unplanned hospital admissions, less episodes of post-operative nausea and less amount of antiemetic medication used in PACU, phase 2 and the first 24 hours post-op (Aim 2). The investigators propose that such differences could play a significant role in surgical outcomes and patient satisfaction in outpatient plastic surgery.
- Being tested
- Tumescent solution with dilute lidocaine and epinephrine, Tumescent Solution with dilute epinephrine
- Keywords
- Pain, postoperative, Postoperative Nausea and Vomiting, Patient Readmission, Time to Discharge
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumescent solution with dilute lidocaine and epinephrineDrug
Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
Tumescent Solution with dilute epinephrineDrug
Tumescent Solution containing dilute epinephrine (1:1,000,000) only
| Study group | Role | What they receive |
|---|---|---|
| Tumescent solution with dilute epinephrine | Active comparator | Subjects in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction. Receives: Drug: Tumescent Solution with dilute epinephrine |
| Tumescent solution with dilute lidocaine and epinephrine | Active comparator | Subjects in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000). Receives: Drug: Tumescent solution with dilute lidocaine and epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain
Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The data points that will be statistically compared will be pain scores determined via a validated pain survey (pain levels on a scale of 0-10 where 10 is the worst pain) and the amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined from responses to survey questions and by reviewing the medical record.
Measured: Up to 24 hours following surgery
Amount of Post-Operative Narcotic Medication Administered
Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined by reviewing the medical record.
Measured: Up to 24 hours following surgery
Secondary outcomes (5)
Post Operative Nausea and Vomiting
The secondary outcomes that will be measured in this study include number of episodes of post-operative nausea (subjective feeling vs. emesis). This data will be attained by reviewing the medical record and through the validated survey questions.
Measured: Up to 24 hours following surgery
Anti-emetic / Intraoperative Medication Administered (mg)
The secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions.
Measured: Up to 24 hours following surgery
Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms)
The secondary outcomes that will be measured in this study include the amount of anti-emetic medication used in the first 24 hours post-op. This data will be attained by reviewing the medical record and through the validated survey questions.
Measured: Up to 24 hours following surgery
Time to Discharge
The patient's medical record will be reviewed to determine the time it took for the patient to be transitioned from the PACU (post anesthesia care unit) till discharge. This includes the time spent in the PACU, time spent in phase 2 and the total time to discharge.
Measured: Up to 24 hours following surgery
Unplanned Hospital Readmission
The patient's medical record will be reviewed to see if the patient was readmitted to the hospital (unplanned) due to complications related to this surgery.
Measured: Up to 1 week following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2014
- Study completionJul 2014
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.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Venkat K Rao, M.D. M.B.A, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602692
- Sponsor's protocol ID
- 2011-0543
- Other IDs
- A539730, SMPH/SURGERY/DENT&P SRG
- Status last verified
- Oct 2020
- First submitted
- 4 May 2012
- Last updated
- 5 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lu L, Fine NA. The efficacy of continuous local anesthetic infiltration in breast surgery: reduction mammaplasty and reconstruction. Plast Reconstr Surg. 2005 Jun;115(7):1927-34; discussion 1935-6. doi: 10.1097/01.prs.0000163332.04220.bd.
PubMed 15923838Rawlani V, Kryger ZB, Lu L, Fine NA. A local anesthetic pump reduces postoperative pain and narcotic and antiemetic use in breast reconstruction surgery: a randomized controlled trial. Plast Reconstr Surg. 2008 Jul;122(1):39-52. doi: 10.1097/PRS.0b013e3181774349.
PubMed 18594373Kryger ZB, Rawlani V, Lu L, Fine NA. Decreased postoperative pain, narcotic, and antiemetic use after breast reduction using a local anesthetic pain pump. Ann Plast Surg. 2008 Aug;61(2):147-52. doi: 10.1097/SAP.0b013e31815a23ef.
PubMed 18650606Schurr MJ, Gordon DB, Pellino TA, Scanlon TA. Continuous local anesthetic infusion for pain management after outpatient inguinal herniorrhaphy. Surgery. 2004 Oct;136(4):761-9. doi: 10.1016/j.surg.2004.06.016.
PubMed 15467660Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Quality improvement guidelines for the treatment of acute pain and cancer pain. American Pain Society Quality of Care Committee. JAMA. 1995 Dec 20;274(23):1874-80. doi: 10.1001/jama.1995.03530230060032.
PubMed 7500539Klein JA. Tumescent technique for regional anesthesia permits lidocaine doses of 35 mg/kg for liposuction. J Dermatol Surg Oncol. 1990 Mar;16(3):248-63. doi: 10.1111/j.1524-4725.1990.tb03961.x.
PubMed 2179348Ostad A, Kageyama N, Moy RL. Tumescent anesthesia with a lidocaine dose of 55 mg/kg is safe for liposuction. Dermatol Surg. 1996 Nov;22(11):921-7. doi: 10.1111/j.1524-4725.1996.tb00634.x.
PubMed 9063507Larson JD, Gutowski KA, Marcus BC, Rao VK, Avery PG, Stacey DH, Yang RZ. The effect of electroacustimulation on postoperative nausea, vomiting, and pain in outpatient plastic surgery patients: a prospective, randomized, blinded, clinical trial. Plast Reconstr Surg. 2010 Mar;125(3):989-94. doi: 10.1097/PRS.0b013e3181ccdc23.
PubMed 20195124Heller L, Kowalski AM, Wei C, Butler CE. Prospective, randomized, double-blind trial of local anesthetic infusion and intravenous narcotic patient-controlled anesthesia pump for pain management after free TRAM flap breast reconstruction. Plast Reconstr Surg. 2008 Oct;122(4):1010-1018. doi: 10.1097/PRS.0b013e3181858c09.
PubMed 18827631Christie BM, Kapur S, Kempton SJ, Hanson SE, Ma Y, Rao VK. A Prospective Randomized Trial Comparing the Effects of Lidocaine in Breast Reduction Surgery. Plast Reconstr Surg. 2017 May;139(5):1074e-1079e. doi: 10.1097/PRS.0000000000003243.
PubMed 28445354
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Tumescence in Breast Reduction Surgery
- ClinicalTrials.gov ID
- NCT01602692
- Acronym / sponsor ID
- 2011-0543
- Keywords
- Pain, postoperative, Postoperative Nausea and Vomiting, Patient Readmission, Time to Discharge
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 May 2012 (estimated)
- Results
- Posted 5 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators' main hypothesis is that in breast reduction surgery, the use of tumescent solution containing both dilute lidocaine and epinephrine will lead to better control of postoperative pain, nausea, vomiting, shorter time through postoperative phases of care, quicker discharge from the hospital and lower numbers of hospital readmissions than the use of tumescent solution containing only dilute epinephrine.
Detailed description
Postoperative pain is often undermanaged in surgical patients. In the outpatient surgery population, such as breast reduction surgery, postoperative pain can lead to increased narcotic use, increased nausea, surgical complications and unplanned hospital admission, in addition to patient discomfort or dissatisfaction. Tumescence is a method of infiltrating tissues, such as the breast, with solutions of very dilute lidocaine and/or very dilute epinephrine in order to provide diffuse local anesthesia, hemostasis, and tissue manipulation. Both types of solution are considered standard care and both at the University of Wisconsin, Madison. There are two main aims to this study. Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. Aim 2 of our study is to determine the effect of dilute lidocaine in tumescent solution on secondary post-operative outcomes following breast reduction surgery. The secondary outcomes that will be measured in this study include average time (minutes) spent in the postanesthesia care unit (PACU), average time (minutes) spent in Phase 2, total time (minutes) between the end of case and discharge home, occurrence of unplanned hospital admission, number of episodes of post-operative nausea (subjective feeling vs. emesis) and amount of anti-emetic medication used in pacu, phase 2 and the first 24 hours post-op (mg). The investigators hypothesize that tumescence with lidocaine and epinephrine will have improved post-operative pain control leading to less narcotic use during the first twenty four hours postoperatively. (Aim 1). The investigators also believe that tumescence with lidocaine and epinephrine will lead to less time spent in PACU, less time spent in Phase2, less time between the end of the case and discharge home, less occurrence of unplanned hospital admissions, less episodes of post-operative nausea and less amount of antiemetic medication used in PACU, phase 2 and the first 24 hours post-op (Aim 2). The investigators propose that such differences could play a significant role in surgical outcomes and patient satisfaction in outpatient plastic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumescent solution with dilute epinephrine | Active comparator | Drug: Tumescent Solution with dilute epinephrineSubjects in this arm of the study will be randomized to receive tumescent solution containing dilute epinephrine (1:1,000,000) during their breast reduction. |
| Tumescent solution with dilute lidocaine and epinephrine | Active comparator | Drug: Tumescent solution with dilute lidocaine and epinephrineSubjects in this arm of the study will receive tumescent solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients presenting for breast reduction surgery at the University of Wisconsin Hospital and Clinics and the University of Wisconsin Transformations Surgery Center and who do not meet any of the exclusion criteria.
Key exclusion criteria (5 listed)
- Women under the age of 18 years
- Breast feeding or pregnant women
- Incarcerated women.
- Women unable to give consent because of impaired decision making ability.
- Women who have reported allergies to the substances that will be used in the study.
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 |
|---|---|---|
| Tumescent solution with dilute lidocaine and epinephrineTumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000) | Drug | Tumescent solution with dilute lidocaine and epinephrine |
| Tumescent Solution with dilute epinephrineTumescent Solution containing dilute epinephrine (1:1,000,000) only | Drug | Tumescent solution with dilute epinephrine |
Primary outcome
Post-operative Pain
Time frame: Up to 24 hours following surgery
Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The data points that will be statistically compared will be pain scores determined via a validated pain survey (pain levels on a scale of 0-10 where 10 is the worst pain) and the amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined from responses to survey questions and by reviewing the medical record.
Amount of Post-Operative Narcotic Medication Administered
Time frame: Up to 24 hours following surgery
Aim 1 is to determine the effect of dilute lidocaine in tumescent solution on post-operative pain following breast reduction surgery. The amount of narcotic medication administered (in Postanesthesia Care Unit (PACU), phase 2 and up to 24 hours post-op) determined by reviewing the medical record.
5 secondary outcomes
Post Operative Nausea and Vomiting
Time frame: Up to 24 hours following surgery
Anti-emetic / Intraoperative Medication Administered (mg)
Time frame: Up to 24 hours following surgery
Anti-emetic / Intraoperative Fentanyl Administered (Measured in Micrograms)
Time frame: Up to 24 hours following surgery
Time to Discharge
Time frame: Up to 24 hours following surgery
Unplanned Hospital Readmission
Time frame: Up to 1 week following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15923838Lu L, Fine NA. The efficacy of continuous local anesthetic infiltration in breast surgery: reduction mammaplasty and reconstruction. Plast Reconstr Surg. 2005 Jun;115(7):1927-34; discussion 1935-6. doi: 10.1097/01.prs.0000163332.04220.bd.
- Background: PubMed 18594373Rawlani V, Kryger ZB, Lu L, Fine NA. A local anesthetic pump reduces postoperative pain and narcotic and antiemetic use in breast reconstruction surgery: a randomized controlled trial. Plast Reconstr Surg. 2008 Jul;122(1):39-52. doi: 10.1097/PRS.0b013e3181774349.
- Background: PubMed 18650606Kryger ZB, Rawlani V, Lu L, Fine NA. Decreased postoperative pain, narcotic, and antiemetic use after breast reduction using a local anesthetic pain pump. Ann Plast Surg. 2008 Aug;61(2):147-52. doi: 10.1097/SAP.0b013e31815a23ef.
- Background: PubMed 15467660Schurr MJ, Gordon DB, Pellino TA, Scanlon TA. Continuous local anesthetic infusion for pain management after outpatient inguinal herniorrhaphy. Surgery. 2004 Oct;136(4):761-9. doi: 10.1016/j.surg.2004.06.016.
- Background: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Background: PubMed 7500539Quality improvement guidelines for the treatment of acute pain and cancer pain. American Pain Society Quality of Care Committee. JAMA. 1995 Dec 20;274(23):1874-80. doi: 10.1001/jama.1995.03530230060032.
- Background: PubMed 2179348Klein JA. Tumescent technique for regional anesthesia permits lidocaine doses of 35 mg/kg for liposuction. J Dermatol Surg Oncol. 1990 Mar;16(3):248-63. doi: 10.1111/j.1524-4725.1990.tb03961.x.
- Background: PubMed 9063507Ostad A, Kageyama N, Moy RL. Tumescent anesthesia with a lidocaine dose of 55 mg/kg is safe for liposuction. Dermatol Surg. 1996 Nov;22(11):921-7. doi: 10.1111/j.1524-4725.1996.tb00634.x.
- Background: PubMed 20195124Larson JD, Gutowski KA, Marcus BC, Rao VK, Avery PG, Stacey DH, Yang RZ. The effect of electroacustimulation on postoperative nausea, vomiting, and pain in outpatient plastic surgery patients: a prospective, randomized, blinded, clinical trial. Plast Reconstr Surg. 2010 Mar;125(3):989-94. doi: 10.1097/PRS.0b013e3181ccdc23.
- Background: PubMed 18827631Heller L, Kowalski AM, Wei C, Butler CE. Prospective, randomized, double-blind trial of local anesthetic infusion and intravenous narcotic patient-controlled anesthesia pump for pain management after free TRAM flap breast reconstruction. Plast Reconstr Surg. 2008 Oct;122(4):1010-1018. doi: 10.1097/PRS.0b013e3181858c09.
- Results publication: PubMed 28445354Christie BM, Kapur S, Kempton SJ, Hanson SE, Ma Y, Rao VK. A Prospective Randomized Trial Comparing the Effects of Lidocaine in Breast Reduction Surgery. Plast Reconstr Surg. 2017 May;139(5):1074e-1079e. doi: 10.1097/PRS.0000000000003243.
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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.
Venkat K Rao, M.D. M.B.A principal investigator
University of Wisconsin, Madison
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 Tumescent solution with dilute lidocaine and epinephrine and Tumescent Solution with dilute epinephrine in people with Pain, Postoperative and Postoperative Nausea and Vomiting, run by University of Wisconsin, Madison 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 5 Oct 2020. 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?
Yes. Results are posted in the registry (first posted 5 Oct 2020). 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?
Post-operative Pain (time frame: Up to 24 hours following surgery). 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?
On the ClinicalTrials.gov record for NCT01602692, which also lists 11 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 5 Oct 2020.