Muscle WeaknessMP-10NCT02739464
Effect of In-Patient Exercise Training on Length of Hospitalization in Burned Patients
A study testing Exercise + SOC PT/OT and SOC PT/OT in people with Muscle Weakness and Late Effect of Burn, run by The University of Texas Medical Branch, Galveston at 4 sites in United States.
Trial summary
This study will measure efficacy of early in-patient exercise as an adjunct to current Standard of Care (SOC) for 96 patients in a multi-centre trial. The secondary purpose is to assess the efficacy of a personalized, structured, and quantifiable exercise program (MP10) carried out soon after admission until hospital… Read more about this study
- Who is it for?
- Ages 7 to 60 years
- Conditions the study is for
- Muscle Weakness, Late Effect of Burn, Muscle; Fatigue, Heart
- What is being tested?
- Exercise + SOC PT/OT and SOC PT/OT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Sep 2014to 25 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female subjects ≥7 to 60 years of age
- >30% TBSA burned, as estimated by the physician in charge
- No evidence of organ failure
Who cannot join
- Active Tuberculosis- based on clinical symptoms and/or abnormal chest x-ray in the upper lobe.
- Electrical burns
- Mental retardation or autism or any other mental disorder that makes it impossible to participate in an exercise program
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of California-Davis/Shriners Hospitals for Children-Sacramento
Davis, California, 95616
University of Texas Medical Branch/Shriners Hospitals for Children-Galveston (lead site)
Galveston, Texas, 77550
United States Army Institute of Surgical Research
San Antonio, Texas, 78234
About this study
Official title: Randomized, Controlled, Multicenter Study of the Effect of In-Patient Exercise Training on Length of Hospitalization, Mental Health, and Physical Performance in Burned Patients
This study will measure efficacy of early in-patient exercise as an adjunct to current Standard of Care (SOC) for 96 patients in a multi-centre trial. The secondary purpose is to assess the efficacy of a personalized, structured, and quantifiable exercise program (MP10) carried out soon after admission until hospital discharge (including during the BICU stay and time on ventilation).
Read the detailed description
After severe burns (≥ 30% total body surface area [TBSA] burns, patients enter a persistent and extensive hypermetabolic and catabolic state. Unfortunately, burn-induced muscle catabolism is exacerbated by the prolonged bed rest and inactivity that accompanies hospitalization, leading to further loss of muscle mass and extreme weakness. The persistence of weakness, fatigue, and muscle catabolism from prolonged bed rest and inactivity during the acute care stage ultimately delays rehabilitation and return to normal physical activities. Studies conducted in non-burn patients have shown that, aside from decreasing muscle mass, prolonged bed rest has a host of other negative physiological consequences.
The primary purpose of this randomized, controlled, multicenter study is being conducted to determine the efficacy of early in-patient exercise, when used as an adjunct to standard of care (SOC), in improving recovery of adults from burns. The secondary purpose is to assess the efficacy of a personalized, structured, and quantifiable exercise program (hereafter referred to as MP10) carried out soon after admission until hospital discharge (including during the BICU stay and time on ventilation). This objective will be met through a multicenter trial in children and adults (7 - 60 years) with ≥30% TBSA burns. Outcome variables will include BICU days, ventilator days, hospital days, peak treadmill time, and lean body mass and psychosocial function (See Section 8 for details).
Methods: Ninety-six subjects will be recruited from four sites (24 subjects each) for this study and all genders and ethnicities will be invited. All subject will have TBSA > 30% and be ages 7-60 years of age. The first objective of this multicenter study will be to characterize the SOC related to physical/occupational therapy of inpatients at four U.S. burn centers, through 25 question surveys. The second portion of the project will involve exercise research. The objective is to assess the efficacy of MP10, in conjunction with existing SOC, in reducing debilitation among discharged burn patients. This will be initiated following surgeon's prescription, roughly 3-5 days following the first surgery after admission.
Ergonomic exercise training for the in-patient subjects will be conducted using Leg and Arm Ergometer equipment, and the training period will be daily for 10 minutes. The duration will be the duration the patient is held in the Burn Intensive Care Unit (BICU). Testing will include the following: Lean mass (assessed via dual energy x-ray absorptiometry (DEXA), Cardiopulmonary and muscle endurance test (peak VO2 on treadmill test), and weekly 6 minute walk test.
Data Analysis: A repeated measure ANOVA will be calculated using lean body mass and peak VO2 as dependent variables with the independent variables of TBA%, duration of hospital stay (and days of ergonomic exercise), ventilator days, and demographics. The purpose of this study is to measure efficacy of exercise training while in BICU for thermal injury patients.
- Being tested
- Exercise + SOC PT/OT, SOC PT/OT
- Keywords
- Burn, Exercise, Ergometer, MP-10
- Medical subject headings
- Muscle Weakness, Fatigue, Burns, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise + SOC PT/OTOther
SOC PT/OTOther
| Study group | Role | What they receive |
|---|---|---|
| Exercise + SOC PT/OT | Experimental | SOC treatment plus a personalized, structured, and quantifiable exercise program (MP10) carried out soon after admission until hospital discharge (including during the BICU stay and time on ventilation. Receives: Other: Exercise + SOC PT/OT |
| SOC PT/OT | Active comparator | Only SOC for treating in-patient burn subjects Receives: Other: SOC PT/OT |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in lean muscle mass
Kilograms
Measured: It is the change from baseline until discharge. Baseline is the time in the ICU, approximately 1-3 months post burn. Discharge is within 3 weeks of the discharge date from the burn ICU. Study duration is at most 5 months depending on the patients burn.
Secondary outcomes (2)
change in VO2 max
The maximal amount of oxygen per kilogram of body mass per minute(ml/kg/min) in a cardiopulmonary exercise test.
Measured: It is the change from baseline until discharge. Baseline is the time in the ICU, approximately 1-3 months post burn. Discharge is within 3 weeks of the discharge date from the burn ICU. Study duration is at most 5 months depending on the patients burn.]
change in distance walked over 6 minutes
6 min walk test measures distance will be recorded in feet.
Measured: It is the change from baseline until discharge. Baseline is the time in the ICU, approximately 1-3 months post burn. Discharge is within 3 weeks of the discharge date from the burn ICU. Study duration is at most 5 months depending on the patients burn.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study start15 Sep 2014
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- United States Army Institute of Surgical Research, University of Texas Southwestern Medical Center, California State University, Sacramento
- Responsible party
- Sponsor
- Investigators
- Oscar Suman, Principal investigator, University of Texas Medical Branch/Shriners Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739464
- Sponsor's protocol ID
- SHC; IRB #14-0432
- Acronym
- MP-10
- Status last verified
- Oct 2020
- First submitted
- 12 Mar 2015
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: ONLY de-identified data will be deposited with main site (UTMB). Subsequently, if data is shared among all sites, it will be always in de-identified manner and stripped of all information that could identify the participant.
Publications
Bloomfield SA. Changes in musculoskeletal structure and function with prolonged bed rest. Med Sci Sports Exerc. 1997 Feb;29(2):197-206. doi: 10.1097/00005768-199702000-00006.
PubMed 9044223Bartone PT. Test-retest reliability of the dispositional resilience scale-15, a brief hardiness scale. Psychol Rep. 2007 Dec;101(3 Pt 1):943-4. doi: 10.2466/pr0.101.3.943-944.
PubMed 18232452Kildal M, Andersson G, Fugl-Meyer AR, Lannerstam K, Gerdin B. Development of a brief version of the Burn Specific Health Scale (BSHS-B). J Trauma. 2001 Oct;51(4):740-6. doi: 10.1097/00005373-200110000-00020.
PubMed 11586169Hart DW, Wolf SE, Mlcak R, Chinkes DL, Ramzy PI, Obeng MK, Ferrando AA, Wolfe RR, Herndon DN. Persistence of muscle catabolism after severe burn. Surgery. 2000 Aug;128(2):312-9. doi: 10.1067/msy.2000.108059.
PubMed 10923010Ferrando AA, Lane HW, Stuart CA, Davis-Street J, Wolfe RR; New Collective Author. Prolonged bed rest decreases skeletal muscle and whole body protein synthesis. Am J Physiol. 1996 Apr;270(4 Pt 1):E627-33. doi: 10.1152/ajpendo.1996.270.4.E627.
PubMed 8928769Ferrando AA, Paddon-Jones D, Wolfe RR. Bed rest and myopathies. Curr Opin Clin Nutr Metab Care. 2006 Jul;9(4):410-5. doi: 10.1097/01.mco.0000232901.59168.e9.
PubMed 16778570Bassey EJ, Bennett T, Birmingham AT, Fentem PH, Fitton D, Goldsmith R. Effects of surgical operation and bed rest on cardiovascular responses to exercise in hospital patients. Cardiovasc Res. 1973 Sep;7(5):588-92. doi: 10.1093/cvr/7.5.588. No abstract available.
PubMed 4753294Convertino V, Hung J, Goldwater D, DeBusk RF. Cardiovascular responses to exercise in middle-aged men after 10 days of bedrest. Circulation. 1982 Jan;65(1):134-40. doi: 10.1161/01.cir.65.1.134.
PubMed 6796287Convertino VA, Bisson R, Bates R, Goldwater D, Sandler H. Effects of antiorthostatic bedrest on the cardiorespiratory responses to exercise. Aviat Space Environ Med. 1981 Apr;52(4):251-5. No abstract available.
PubMed 7283897Greenleaf JE, Wade CE, Leftheriotis G; New Collective Author. Orthostatic responses following 30-day bed rest deconditioning with isotonic and isokinetic exercise training. Aviat Space Environ Med. 1989 Jun;60(6):537-42.
PubMed 2751583Hung J, Goldwater D, Convertino VA, McKillop JH, Goris ML, DeBusk RF. Mechanisms for decreased exercise capacity after bed rest in normal middle-aged men. Am J Cardiol. 1983 Jan 15;51(2):344-8. doi: 10.1016/s0002-9149(83)80063-0.
PubMed 6823849Miller PB, Johnson RL, Lamb LE. Effects of moderate physical exercise during four weeks of bed rest on circulatory functions in man. Aerosp Med. 1965 Nov;36(11):1077-82. No abstract available.
PubMed 5860109Convertino V, Hoffler GW; New Collective Author. Cardiovascular physiology. Effects of microgravity. J Fla Med Assoc. 1992 Aug;79(8):517-24.
PubMed 1402772Convertino VA; New Collective Author. Effects of exercise and inactivity on intravascular volume and cardiovascular control mechanisms. Acta Astronaut. 1992 Jul;27:123-9. doi: 10.1016/0094-5765(92)90188-o.
PubMed 11537577Dudley GA, Gollnick PD, Convertino VA, Buchanan P. Changes of muscle function and size with bedrest. Physiologist. 1989 Feb;32(1 Suppl):S65-6. No abstract available.
PubMed 2727110
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Multicenter Study of the Effect of In-Patient Exercise Training on Length of Hospitalization, Mental Health, and Physical Performance in Burned Patients
- ClinicalTrials.gov ID
- NCT02739464
- Acronym / sponsor ID
- MP-10 / SHC; IRB #14-0432
- Keywords
- Burn, Exercise, Ergometer, MP-10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- United States Army Institute of Surgical Research, University of Texas Southwestern Medical Center, California State University, Sacramento
- Study start
- 15 Sep 2014 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 15 Apr 2016 (estimated)
- 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 study will measure efficacy of early in-patient exercise as an adjunct to current Standard of Care (SOC) for 96 patients in a multi-centre trial. The secondary purpose is to assess the efficacy of a personalized, structured, and quantifiable exercise program (MP10) carried out soon after admission until hospital discharge (including during the BICU stay and time on ventilation).
Detailed description
After severe burns (≥ 30% total body surface area [TBSA] burns, patients enter a persistent and extensive hypermetabolic and catabolic state. Unfortunately, burn-induced muscle catabolism is exacerbated by the prolonged bed rest and inactivity that accompanies hospitalization, leading to further loss of muscle mass and extreme weakness. The persistence of weakness, fatigue, and muscle catabolism from prolonged bed rest and inactivity during the acute care stage ultimately delays rehabilitation and return to normal physical activities. Studies conducted in non-burn patients have shown that, aside from decreasing muscle mass, prolonged bed rest has a host of other negative physiological consequences.
The primary purpose of this randomized, controlled, multicenter study is being conducted to determine the efficacy of early in-patient exercise, when used as an adjunct to standard of care (SOC), in improving recovery of adults from burns. The secondary purpose is to assess the efficacy of a personalized, structured, and quantifiable exercise program (hereafter referred to as MP10) carried out soon after admission until hospital discharge (including during the BICU stay and time on ventilation). This objective will be met through a multicenter trial in children and adults (7 - 60 years) with ≥30% TBSA burns. Outcome variables will include BICU days, ventilator days, hospital days, peak treadmill time, and lean body mass and psychosocial function (See Section 8 for details).
Methods: Ninety-six subjects will be recruited from four sites (24 subjects each) for this study and all genders and ethnicities will be invited. All subject will have TBSA > 30% and be ages 7-60 years of age. The first objective of this multicenter study will be to characterize the SOC related to physical/occupational therapy of inpatients at four U.S. burn centers, through 25 question surveys. The second portion of the project will involve exercise research. The objective is to assess the efficacy of MP10, in conjunction with existing SOC, in reducing debilitation among discharged burn patients. This will be initiated following surgeon's prescription, roughly 3-5 days following the first surgery after admission.
Ergonomic exercise training for the in-patient subjects will be conducted using Leg and Arm Ergometer equipment, and the training period will be daily for 10 minutes. The duration will be the duration the patient is held in the Burn Intensive Care Unit (BICU). Testing will include the following: Lean mass (assessed via dual energy x-ray absorptiometry (DEXA), Cardiopulmonary and muscle endurance test (peak VO2 on treadmill test), and weekly 6 minute walk test.
Data Analysis: A repeated measure ANOVA will be calculated using lean body mass and peak VO2 as dependent variables with the independent variables of TBA%, duration of hospital stay (and days of ergonomic exercise), ventilator days, and demographics. The purpose of this study is to measure efficacy of exercise training while in BICU for thermal injury patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + SOC PT/OT | Experimental | Other: Exercise + SOC PT/OTSOC treatment plus a personalized, structured, and quantifiable exercise program (MP10) carried out soon after admission until hospital discharge (including during the BICU stay and time on ventilation. |
| SOC PT/OT | Active comparator | Other: SOC PT/OTOnly SOC for treating in-patient burn subjects |
Who may qualify
- Ages
- 7 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male and female subjects ≥7 to 60 years of age
- >30% TBSA burned, as estimated by the physician in charge
- No evidence of organ failure
Key exclusion criteria (4 listed)
- Active Tuberculosis- based on clinical symptoms and/or abnormal chest x-ray in the upper lobe.
- Electrical burns
- Mental retardation or autism or any other mental disorder that makes it impossible to participate in an exercise program
- Pregnancy
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 |
|---|---|---|
| Exercise + SOC PT/OT | Other | Exercise + SOC PT/OT |
| SOC PT/OT | Other | SOC PT/OT |
Primary outcome
change in lean muscle mass
Time frame: It is the change from baseline until discharge. Baseline is the time in the ICU, approximately 1-3 months post burn. Discharge is within 3 weeks of the discharge date from the burn ICU. Study duration is at most 5 months depending on the patients burn.
Kilograms
2 secondary outcomes
change in VO2 max
Time frame: It is the change from baseline until discharge. Baseline is the time in the ICU, approximately 1-3 months post burn. Discharge is within 3 weeks of the discharge date from the burn ICU. Study duration is at most 5 months depending on the patients burn.]
change in distance walked over 6 minutes
Time frame: It is the change from baseline until discharge. Baseline is the time in the ICU, approximately 1-3 months post burn. Discharge is within 3 weeks of the discharge date from the burn ICU. Study duration is at most 5 months depending on the patients burn.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Background: PubMed 9044223Bloomfield SA. Changes in musculoskeletal structure and function with prolonged bed rest. Med Sci Sports Exerc. 1997 Feb;29(2):197-206. doi: 10.1097/00005768-199702000-00006.
- Background: PubMed 18232452Bartone PT. Test-retest reliability of the dispositional resilience scale-15, a brief hardiness scale. Psychol Rep. 2007 Dec;101(3 Pt 1):943-4. doi: 10.2466/pr0.101.3.943-944.
- Background: PubMed 11586169Kildal M, Andersson G, Fugl-Meyer AR, Lannerstam K, Gerdin B. Development of a brief version of the Burn Specific Health Scale (BSHS-B). J Trauma. 2001 Oct;51(4):740-6. doi: 10.1097/00005373-200110000-00020.
- Results publication: PubMed 10923010Hart DW, Wolf SE, Mlcak R, Chinkes DL, Ramzy PI, Obeng MK, Ferrando AA, Wolfe RR, Herndon DN. Persistence of muscle catabolism after severe burn. Surgery. 2000 Aug;128(2):312-9. doi: 10.1067/msy.2000.108059.
- Results publication: PubMed 8928769Ferrando AA, Lane HW, Stuart CA, Davis-Street J, Wolfe RR; New Collective Author. Prolonged bed rest decreases skeletal muscle and whole body protein synthesis. Am J Physiol. 1996 Apr;270(4 Pt 1):E627-33. doi: 10.1152/ajpendo.1996.270.4.E627.
- Results publication: PubMed 16778570Ferrando AA, Paddon-Jones D, Wolfe RR. Bed rest and myopathies. Curr Opin Clin Nutr Metab Care. 2006 Jul;9(4):410-5. doi: 10.1097/01.mco.0000232901.59168.e9.
- Results publication: PubMed 4753294Bassey EJ, Bennett T, Birmingham AT, Fentem PH, Fitton D, Goldsmith R. Effects of surgical operation and bed rest on cardiovascular responses to exercise in hospital patients. Cardiovasc Res. 1973 Sep;7(5):588-92. doi: 10.1093/cvr/7.5.588. No abstract available.
- Results publication: PubMed 6796287Convertino V, Hung J, Goldwater D, DeBusk RF. Cardiovascular responses to exercise in middle-aged men after 10 days of bedrest. Circulation. 1982 Jan;65(1):134-40. doi: 10.1161/01.cir.65.1.134.
- Results publication: PubMed 7283897Convertino VA, Bisson R, Bates R, Goldwater D, Sandler H. Effects of antiorthostatic bedrest on the cardiorespiratory responses to exercise. Aviat Space Environ Med. 1981 Apr;52(4):251-5. No abstract available.
- Results publication: PubMed 2751583Greenleaf JE, Wade CE, Leftheriotis G; New Collective Author. Orthostatic responses following 30-day bed rest deconditioning with isotonic and isokinetic exercise training. Aviat Space Environ Med. 1989 Jun;60(6):537-42.
- Results publication: PubMed 6823849Hung J, Goldwater D, Convertino VA, McKillop JH, Goris ML, DeBusk RF. Mechanisms for decreased exercise capacity after bed rest in normal middle-aged men. Am J Cardiol. 1983 Jan 15;51(2):344-8. doi: 10.1016/s0002-9149(83)80063-0.
- Results publication: PubMed 5860109Miller PB, Johnson RL, Lamb LE. Effects of moderate physical exercise during four weeks of bed rest on circulatory functions in man. Aerosp Med. 1965 Nov;36(11):1077-82. No abstract available.
- Individual participant dataSharing planned: Yes. ONLY de-identified data will be deposited with main site (UTMB). Subsequently, if data is shared among all sites, it will be always in de-identified manner and stripped of all information that could identify the participant.
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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.
Oscar Suman principal investigator
University of Texas Medical Branch/Shriners Hospital for Children
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise + SOC PT/OT and SOC PT/OT in people with Muscle Weakness and Late Effect of Burn, run by The University of Texas Medical Branch, Galveston at 4 sites 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 3 inclusion and 4 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 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in lean muscle mass (time frame: It is the change from baseline until discharge. Baseline is the time in the ICU, approximately 1-3 months post burn. Discharge is within 3 weeks of the discharge date from the burn ICU. Study duration is at most 5 months depending on the patients burn.). 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 NCT02739464, which also lists 40 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 6 Nov 2020.