Refractory Lumbar Disc ProlapseNCT03933150
Caudal Epidural Steroid Injection Ultrasound Guided in LDP
A study testing ultrasound guided caudal epidural injection in people with Refractory Lumbar Disc Prolapse, run by Mansoura University at 1 site in Egypt.
Trial summary
Patients with LDP with unilateral radiculopathy diagnosed by routine clinical examination and MRI, in whom conservative treatment (medical treatment and physiotherapy) failed for more than 6 weeks and refuse surgery or were unfit for surgery A. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Refractory Lumbar Disc Prolapse
- What is being tested?
- ultrasound guided caudal epidural injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Dec 2019
- 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 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with LDP with unilateral radiculopathy diagnosed by routine clinical examination and MRI,
Who cannot join
- Vertebral fractures, direct trauma, spinal inflammatory disease, spinal infection, bleeding tendency, LBP with tumors, bilateral radiculopathy, cauda equina syndrome, spinal canal stenosis, post-laminectomy surgery, diabetic and hypertensive patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine Mansoura University
Al Mansurah, Dakahlia Provence, 050
About this study
Official title: Caudal Epidural Steroid Injection Ultrasound Guided Versus Fluoroscopy Guided in Treatment of Refractory Lumbar Disc Prolapse With Radiculopathy
Patients with LDP with unilateral radiculopathy diagnosed by routine clinical examination and MRI, in whom conservative treatment (medical treatment and physiotherapy) failed for more than 6 weeks and refuse surgery or were unfit for surgery A. Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients.
All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor
Read the detailed description
228 patients suffering from LDP with radiculopathy,recruited from the outpatient Clinic of Rheumatology and Rehabilitation department at Mansoura University Hospital were assessed for eligibility to participate in this study.
Those who met the inclusion criteria wereselected. Conversely, those who did not meet inclusion criteria or met the exclusion criteria were excluded.Accordingly, 136 patients who met the inclusion criteria were divided into two groups:
- Group 1: included 68 patients who received US-guided CESI. They were 39 females and 29 males. Their age ranged from 23 to 65.
- Group 2: included 68 patients who received FL-guided CESI. They were 38 females and 30 males. Their age ranged from 22 to 62.
A written consent was obtained from each participant sharing in this study. The institutional research board of faculty of medicine, Mansoura University, approved this study, code: MS/16.06.46.
Inclusion Criteria:
Patients with LDP with unilateral radiculopathy diagnosed by routine clinical examination and MRI, in whom conservative treatment (medical treatment and physiotherapy) failed for more than 6 weeks and refuse surgery or were unfit for surgery
Exclusion Criteria:
Vertebral fractures, direct trauma, spinal inflammatory disease, spinal infection, bleeding tendency, LBP with tumors, bilateral radiculopathy, cauda equina syndrome, spinal canal stenosis, post-laminectomy surgery, diabetic and hypertensive patients.
Study design:
Randomized controlled clinical trial.
Type of randomization:
Patients were randomly divided into 2 treatment groups. For allotting, bunches bits of paper were set up in a similar number of patients. The name of treatment strategies was composed on the bits of paper. At that point, patients were made a request to take one paper and this is the treatment sort for every individual was determined.
- Clinical Evaluation:
- History Taking:including
- Personal history
- Name, age, sex, occupation, marital status, offspring and smoking.
- Present History
- Pain: onset, course, duration, site, nature, radiation and modifying factors.
- Associated symptoms: fever, unexplained weight loss, night pain, chronic cough, stiffness, pain in other joints, skin lesions, diarrhea, urogenital diseases, eye lesions, anxiety, depression, fatigue or sleep disturbance.
- Neurological symptoms: numbness, paresthesia, muscle weakness, claudication, or sphincteric disturbance.
- Articular symptoms : of other joints including cervical, hips and knees
- Symptoms related to other systems: respiratory, cardiovascular, gastrointestinal, urinary, and gynecological systems.
- Work related conditions
- Past History III. Assessment of pain Patients were assessed before treatment, 1 month and 3 months after the injection using VAS.
IV. Assessment of pain and function Patients were assessed before treatment, 1 month and 3 months after the injection procedure by the ODI.
All the eligible patients were treated with either US-guided or FL-guided CESI, were administered a mixture of 20 cc (0.5% lidocaine 18.0 mL \&2ml of triamcinolone acetonide 40 mg/1ml) (Bicket, et al., 2015; Manchikanti, et al., 2015b).
- Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients.
- Fluoroscopy-Guided CESI (Group 2) All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor
- Conditions
- Refractory Lumbar Disc Prolapse
- Being tested
- ultrasound guided caudal epidural injection
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided caudal epidural injectionDevice
Also called fluoroscopy guided caudal epidural injection
- Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients.
- Fluoroscopy-Guided CESI (Group 2) All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor
| Study group | Role | What they receive |
|---|---|---|
| ultrasoun guided caudal epidural injection | Other | A. Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients. Receives: Device: ultrasound guided caudal epidural injection |
| fluoroscopy guided caudal epidural injection | Other | B. Fluoroscopy-Guided CESI (Group 2) All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor Receives: Device: ultrasound guided caudal epidural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of degree of pain from base line Patients were assessed before treatment, 1 month and 3 months after the injection using VAS.
Visual analog scale for pain is a measurement tool that measures a characteristic or attitude that is believed to range across a continuum of values.It is usually a horizontal line, 100 mm in length, anchored by verbal descriptors at each end: 'no pain' and 'worst pain possible'. The patients place a mark on the line that represented their level of pain intensity. The distance from the left-hand side was measured in millimeters. This distance quantifies pain level. The following cut points on has been suggested: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100mm) (Smeets, et al., 2011; Elfving, et al., 2016).
Measured: assessed immediately before injection,1 month after injection,3 month after injection
change of Straight leg raising test (SLRT) (Lasègue's sign from base line
One of the most common clinical diagnostic tests (Iversen, et al., 2013). The patient lies on a table in supine position. With one hand set over the knee of the leg being examined, the examiner applies enough firm pressureto keep the knee in full extension. With the alternate hand cupped under the heel, the examiner raises the straight limb gradually. Sciatic nerve compression is indicated if pain is agonized or worsened on raising the leg to a level more than 25° but lower than 75º. The ankle is dorsiflexed as the leg is held at the limit of straight-leg raising (onset). Symptoms are exaggerated in persons who have nerve root compression as the reason (De Luigi and Fitzpatrick, 2011).
Measured: assessed immediately before injection,1 month after injection,3 month after injection
change of Femoral stretch test from base line
While patient lies prone, the knee is inactively flexed to the thigh and the hip is pas extended; thetest ispositive if the patient encounters pain in front of the thigh (Magee, 2013).
Measured: assessed immediately before injection,1 month after injection,3 month after injection
change of Modified Schober's test from base line
While the patient is standing erect, marks are made 5 cm below and 10 cm above the lumbosacral junction (dimples of Venus) and the distance between the two marks is measured. Then measurement is repeated with the patient in full forward flexion (Fig. 9). In general, the measure should increase by at least 5 cm to 21 cm. An increase of less than 5 cm advocates decreased lumbar spinal mobility.
Measured: assessed immediately before injection,1 month after injection,3 month after injection
Secondary outcomes (1)
change of pain and function from base line: Oswestry Disability Index Patients were assessed before treatment, 1 month and 3 months after the injection procedure by the ODI.
Oswestry Disability Index (Fairbank and Pynsent, 2000) It is a self-administered questionnaire compromised of 10 sections; each section is scored on a 0-5 scale, 5 representing the greatest disability (see the Appendix).
It is composed of 10 short-termsectors. The index is calculated by dividing the summed score by the total possible score, after that it is multiplied by 100 and expressed as a percentage. Thus, for the not answered questions, the denominator is reduced by 5 for each.
Interpretation of scores:
0% to 20%:minimal disability:The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise.
21%-40%: moderate disability:The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative
Measured: assessed immediately before injection,1 month after injection,3 month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Jun 2019
- Primary completion1 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Lumbar Disc ProlapseStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Type of randomization: Patients were randomly divided into 2 treatment groups. For allotting, bunches bits of paper were set up in a similar number of patients. The name of treatment strategies was composed on the bits of paper. At that point, patients were made a request to take one paper and this is the treatment sort for every individual was determined.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933150
- Sponsor's protocol ID
- code: MS/16.06.46.
- Status last verified
- May 2019
- First submitted
- 24 Apr 2019
- Last updated
- 23 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal Epidural Steroid Injection Ultrasound Guided Versus Fluoroscopy Guided in Treatment of Refractory Lumbar Disc Prolapse With Radiculopathy
- ClinicalTrials.gov ID
- NCT03933150
- Acronym / sponsor ID
- code: MS/16.06.46.
- Conditions
- Refractory Lumbar Disc Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 1 May 2019 (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.
Patients with LDP with unilateral radiculopathy diagnosed by routine clinical examination and MRI, in whom conservative treatment (medical treatment and physiotherapy) failed for more than 6 weeks and refuse surgery or were unfit for surgery A. Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients.
All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor
Detailed description
228 patients suffering from LDP with radiculopathy,recruited from the outpatient Clinic of Rheumatology and Rehabilitation department at Mansoura University Hospital were assessed for eligibility to participate in this study.
Those who met the inclusion criteria wereselected. Conversely, those who did not meet inclusion criteria or met the exclusion criteria were excluded.Accordingly, 136 patients who met the inclusion criteria were divided into two groups:
- Group 1: included 68 patients who received US-guided CESI. They were 39 females and 29 males. Their age ranged from 23 to 65.
- Group 2: included 68 patients who received FL-guided CESI. They were 38 females and 30 males. Their age ranged from 22 to 62.
A written consent was obtained from each participant sharing in this study. The institutional research board of faculty of medicine, Mansoura University, approved this study, code: MS/16.06.46.
Inclusion Criteria:
Patients with LDP with unilateral radiculopathy diagnosed by routine clinical examination and MRI, in whom conservative treatment (medical treatment and physiotherapy) failed for more than 6 weeks and refuse surgery or were unfit for surgery
Exclusion Criteria:
Vertebral fractures, direct trauma, spinal inflammatory disease, spinal infection, bleeding tendency, LBP with tumors, bilateral radiculopathy, cauda equina syndrome, spinal canal stenosis, post-laminectomy surgery, diabetic and hypertensive patients.
Study design:
Randomized controlled clinical trial.
Type of randomization:
Patients were randomly divided into 2 treatment groups. For allotting, bunches bits of paper were set up in a similar number of patients. The name of treatment strategies was composed on the bits of paper. At that point, patients were made a request to take one paper and this is the treatment sort for every individual was determined.
- Clinical Evaluation:
- History Taking:including
- Personal history
- Name, age, sex, occupation, marital status, offspring and smoking.
- Present History
- Pain: onset, course, duration, site, nature, radiation and modifying factors.
- Associated symptoms: fever, unexplained weight loss, night pain, chronic cough, stiffness, pain in other joints, skin lesions, diarrhea, urogenital diseases, eye lesions, anxiety, depression, fatigue or sleep disturbance.
- Neurological symptoms: numbness, paresthesia, muscle weakness, claudication, or sphincteric disturbance.
- Articular symptoms : of other joints including cervical, hips and knees
- Symptoms related to other systems: respiratory, cardiovascular, gastrointestinal, urinary, and gynecological systems.
- Work related conditions
- Past History III. Assessment of pain Patients were assessed before treatment, 1 month and 3 months after the injection using VAS.
IV. Assessment of pain and function Patients were assessed before treatment, 1 month and 3 months after the injection procedure by the ODI.
All the eligible patients were treated with either US-guided or FL-guided CESI, were administered a mixture of 20 cc (0.5% lidocaine 18.0 mL \&2ml of triamcinolone acetonide 40 mg/1ml) (Bicket, et al., 2015; Manchikanti, et al., 2015b).
- Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients.
- Fluoroscopy-Guided CESI (Group 2) All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Type of randomization: Patients were randomly divided into 2 treatment groups. For allotting, bunches bits of paper were set up in a similar number of patients. The name of treatment strategies was composed on the bits of paper. At that point, patients were made a request to take one paper and this is the treatment sort for every individual was determined.
| Arm | Type | Receives |
|---|---|---|
| ultrasoun guided caudal epidural injection | Other | Device: ultrasound guided caudal epidural injectionA. Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients. |
| fluoroscopy guided caudal epidural injection | Other | Device: ultrasound guided caudal epidural injectionB. Fluoroscopy-Guided CESI (Group 2) All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with LDP with unilateral radiculopathy diagnosed by routine clinical examination and MRI,
Key exclusion criteria (1 listed)
- Vertebral fractures, direct trauma, spinal inflammatory disease, spinal infection, bleeding tendency, LBP with tumors, bilateral radiculopathy, cauda equina syndrome, spinal canal stenosis, post-laminectomy surgery, diabetic and hypertensive patients.
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 |
|---|---|---|
| ultrasound guided caudal epidural injectionAlso: fluoroscopy guided caudal epidural injectionA. Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients. B. Fluoroscopy-Guided CESI (Group 2) All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor | Device | fluoroscopy guided caudal epidural injection, ultrasoun guided caudal epidural injection |
Primary outcome
change of degree of pain from base line Patients were assessed before treatment, 1 month and 3 months after the injection using VAS.
Time frame: assessed immediately before injection,1 month after injection,3 month after injection
Visual analog scale for pain is a measurement tool that measures a characteristic or attitude that is believed to range across a continuum of values.It is usually a horizontal line, 100 mm in length, anchored by verbal descriptors at each end: 'no pain' and 'worst pain possible'. The patients place a mark on the line that represented their level of pain intensity. The distance from the left-hand side was measured in millimeters. This distance quantifies pain level. The following cut points on has been suggested: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100mm) (Smeets, et al., 2011; Elfving, et al., 2016).
change of Straight leg raising test (SLRT) (Lasègue's sign from base line
Time frame: assessed immediately before injection,1 month after injection,3 month after injection
One of the most common clinical diagnostic tests (Iversen, et al., 2013). The patient lies on a table in supine position. With one hand set over the knee of the leg being examined, the examiner applies enough firm pressureto keep the knee in full extension. With the alternate hand cupped under the heel, the examiner raises the straight limb gradually. Sciatic nerve compression is indicated if pain is agonized or worsened on raising the leg to a level more than 25° but lower than 75º. The ankle is dorsiflexed as the leg is held at the limit of straight-leg raising (onset). Symptoms are exaggerated in persons who have nerve root compression as the reason (De Luigi and Fitzpatrick, 2011).
change of Femoral stretch test from base line
Time frame: assessed immediately before injection,1 month after injection,3 month after injection
While patient lies prone, the knee is inactively flexed to the thigh and the hip is pas extended; thetest ispositive if the patient encounters pain in front of the thigh (Magee, 2013).
change of Modified Schober's test from base line
Time frame: assessed immediately before injection,1 month after injection,3 month after injection
While the patient is standing erect, marks are made 5 cm below and 10 cm above the lumbosacral junction (dimples of Venus) and the distance between the two marks is measured. Then measurement is repeated with the patient in full forward flexion (Fig. 9). In general, the measure should increase by at least 5 cm to 21 cm. An increase of less than 5 cm advocates decreased lumbar spinal mobility.
1 secondary outcome
change of pain and function from base line: Oswestry Disability Index Patients were assessed before treatment, 1 month and 3 months after the injection procedure by the ODI.
Time frame: assessed immediately before injection,1 month after injection,3 month after injection
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 23 Mar 2020.
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 study testing ultrasound guided caudal epidural injection in people with Refractory Lumbar Disc Prolapse, run by Mansoura University at 1 site in Egypt.
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 1 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 23 Mar 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 Egypt. 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 of degree of pain from base line Patients were assessed before treatment, 1 month and 3 months after the injection using VAS. (time frame: assessed immediately before injection,1 month after injection,3 month after injection). The study lists 4 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 23 Mar 2020.