DexamethasonePhase 4NCT03043495
Dexamethasone Dose in Low Volume Bupivacaine USG Supraclavicular Block
A Phase 4 study testing Ultrasound guided supraclavicular brachial plexus block and Dexamethasone in people with Dexamethasone and Supraclavicular Brachial Plexus Block, run by Eslam Ayman Mohamed Shawki at 1 site in Egypt.
Trial summary
A dose-ranging study to test various doses of Dexamethasone (2, 4 \& 8 mg) to be used as an adjuvant to Local anesthetic drugs in ultrasound guided low volume Supraclavicular brachial plexus block to find the best balance between valuable effects (mainly duration of analgesic Effect) and side-effects (mainly increased… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dexamethasone, Supraclavicular Brachial Plexus Block
- What is being tested?
- Ultrasound guided supraclavicular brachial plexus block and Dexamethasone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2016to 1 Jun 2018
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing surgeries in the upper limb (arm, forearm or hand)
Who cannot join
- Coagulopathies (with prothrombin concentration less than 60% or INR more than 1.5)
- In-ability to postpone anti-coagulation medications.
- Infection or injury or a lesion at the block site.
- Suspected cervical vertebral column injury necessitating using a neck collar.
- A compromised lung on the contralateral side of the block (Pneumothorax, hemothorax or Pneumonectomy).
- Traumatic vascular injuries or operative interventions (Surgical harvesting) involving arteries of the upper limb on the operative side.
Show all 9Show fewer
- Patients with communication difficulties.
- Hypersensitivity to local anesthetics and/or Dexamethasone.
- Patients on perioperative intravenous (IV) steroids.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)
Cairo, Cairo Governorate
Eslam A Shawki, M.D, '+201225771017, eslam.ayman@kasralainy.edu.eg
About this study
Official title: The Optimal Dose Of Dexamethasone To Be Used As An Adjuvant To Low Volume Bupivacaine Ultrasound Guided Supraclavicular Brachial Plexus Block. A Randomized Controlled Double Blinded Dose Ranging Study
A dose-ranging study to test various doses of Dexamethasone (2, 4 \& 8 mg) to be used as an adjuvant to Local anesthetic drugs in ultrasound guided low volume Supraclavicular brachial plexus block to find the best balance between valuable effects (mainly duration of analgesic Effect) and side-effects (mainly increased random blood sugar levels)
Read the detailed description
Brachial plexus nerve blocks (BPBs) for upper extremity surgery provide superior analgesia and reduce opioid consumption. Supraclavicular block anesthetizes the brachial plexus where it is in its most compact form, thus providing a complete and reliable block for upper extremity surgery. Ultrasound guided single injection (SI) and triple injection (TI) techniques were found to provide the same degree of surgical anesthesia at 30 minutes while the TI technique needed more time to perform.
Many studies were conducted to examine the effect of perineural Dexamethasone as a local anesthetic adjuvant in low volume peripheral nerve blocks were it was found to increase the mean duration of analgesia (sensory block) with short, medium and long acting local anesthetics as well as the duration of motor blockade, with a reduction in pain scores at rest during the intermediate (8-12 h) and late (24 h) postoperative periods and in movement at all times. At 24 postoperative hours, cumulative morphine consumption and the rate of nausea or vomiting were also reduced without any reported related serious adverse effects, also the value of its concomitant intravenous use in prolonging the duration of analgesia after regional blocks was studied with promising results that can sometimes be compared to the perineural route but more short-lived and associated with higher increase in blood glucose levels. Dexamethasone's mechanism of action may result from decreased nociceptive C-fibre activity via a direct effect on glucocorticoid receptors and inhibitory effect on potassium channels.(8) Other authors suggest a local vasoconstrictive effect, resulting in reduced local anaesthetic absorption or a systemic anti-inflammatory effect following vascular uptake of the drug.
A debate exists whether perineural corticosteroids are harmful or not, but reports of neurotoxicity seem to be related mainly to the preservative benzyl alcohol and the vehicle polyethylene glycol found in some preparations, also may be related to the presence of insoluble steroid particulate matter in the injectate. Dexamethasone is non-particulate and can be found in a preservative-free formulation. In addition, no significant long-term electrophysiological, behavioural or histological effects for corticosteroids were identified on rat sciatic nerve tissue even some data suggest dexamethasone may actually be neuroprotective. In reality, perineural corticosteroid injections with and without preservative are widely used throughout the world.
Various doses of Dexamethasone were used in local anaesthetic mixtures in regional blocks in various studies, including 4, 5, 8 and 10 mg. In a recent review \& meta-analysis by E. Albrecht and his colleagues, sub-group analysis revealed no association between the total dose of perineural Dexamethasone and the mean increase in duration of analgesia showing that Dose-finding studies are needed to better define the optimal balance between dose, effects and side-effects, particularly at doses lower than 4 mg.
- Being tested
- Ultrasound guided supraclavicular brachial plexus block, Dexamethasone
- Keywords
- dexamethasone, supraclavicular brachial plexus block, ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided supraclavicular brachial plexus blockProcedure or surgery
ultrasound guided Supraclavicular brachial plexus block
DexamethasoneDrug
Also called Decadron
Various doses of Dexamethasone (2, 4 \& 8 mg) to be used as an Adjuvant to Local anesthetic drugs
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 0.5ml (2mg) Dexamethasone, 1.5ml Normal saline. Receives: Procedure: Ultrasound guided supraclavicular brachial plexus block; Drug: Dexamethasone |
| Group B | Active comparator | N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 1ml (4mg) Dexamethasone, 1ml Normal saline. Receives: Procedure: Ultrasound guided supraclavicular brachial plexus block; Drug: Dexamethasone |
| Group C | Active comparator | N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml (8mg) Dexamethasone. Receives: Procedure: Ultrasound guided supraclavicular brachial plexus block; Drug: Dexamethasone |
| Group Control | Active comparator | N-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml Normal saline. Receives: Procedure: Ultrasound guided supraclavicular brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
The time between injection of Local anesthetic mixture during performing the block and time of administration of the first dose of rescue analgesia at VAS equal or more than 4
Measured: 24 hours
Secondary outcomes (5)
Duration of motor block
The time between injection of Local anesthetic mixture during performing the block and regaining full motor power in the distribution of all 4 nerves represented by score 6 on Modified Lovett rating scale
Measured: 24 hours
Patient Satisfaction score
A point on a 10 point numeric scale where 0 is very dissatisfied and 10 very satisfied one time at the end of the first postoperative 24 hours
Measured: 24 hours
Random Blood glucose levels
Random blood glucose level readings will be obtained from the patient using fast strip test (ACCU-CHEK.) First, upon arrival to the operating theatre, then at the end of the operation then every 8 hours in the first 24 hours postoperatively
Measured: 24 hours
Incidence of PONV
Incidence of postoperative nausea and vomiting
Measured: 24 hours
Incidence of complications
Incidence of Pneumothorax, Nerve injury, Haematoma formation, Intravascular injection
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start1 Oct 2016
- Primary completion1 Apr 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DexamethasoneStudies 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
- Model description
- The patients will be randomized to 4 groups: * Group A: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 0.5ml (2mg) Dexamethasone, 1.5ml Normal saline. * Group B: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 1ml (4mg) Dexamethasone, 1ml Normal saline. * Group C: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml (8mg) Dexamethasone. * Group Control: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml Normal saline.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eslam Ayman Mohamed Shawki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eslam Ayman Mohamed Shawki, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043495
- Sponsor's protocol ID
- DexSupraClav
- Status last verified
- Feb 2017
- First submitted
- 1 Feb 2017
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
PubMed 20565394Neal JM, Hebl JR, Gerancher JC, Hogan QH. Brachial plexus anesthesia: essentials of our current understanding. Reg Anesth Pain Med. 2002 Jul-Aug;27(4):402-28. doi: 10.1053/rapm.2002.34377. No abstract available.
PubMed 12132064Al Harbi M, Kaki AM, Kamal A, El-Dawlatly A, Daghistani M, El Tahan MR. A survey of the practice of regional anesthesia in Saudi Arabia. Saudi J Anaesth. 2013 Oct;7(4):367-70. doi: 10.4103/1658-354X.121041.
PubMed 24348284Rosenfeld DM, Ivancic MG, Hattrup SJ, Renfree KJ, Watkins AR, Hentz JG, Gorlin AW, Spiro JA, Trentman TL. Perineural versus intravenous dexamethasone as adjuncts to local anaesthetic brachial plexus block for shoulder surgery. Anaesthesia. 2016 Apr;71(4):380-8. doi: 10.1111/anae.13409. Epub 2016 Feb 22.
PubMed 26899862Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15.
PubMed 23587875Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14.
PubMed 25123271
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Optimal Dose Of Dexamethasone To Be Used As An Adjuvant To Low Volume Bupivacaine Ultrasound Guided Supraclavicular Brachial Plexus Block. A Randomized Controlled Double Blinded Dose Ranging Study
- ClinicalTrials.gov ID
- NCT03043495
- Acronym / sponsor ID
- DexSupraClav
- Keywords
- dexamethasone, supraclavicular brachial plexus block, ultrasound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eslam Ayman Mohamed ShawkiUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Apr 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 6 Feb 2017 (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.
A dose-ranging study to test various doses of Dexamethasone (2, 4 \& 8 mg) to be used as an adjuvant to Local anesthetic drugs in ultrasound guided low volume Supraclavicular brachial plexus block to find the best balance between valuable effects (mainly duration of analgesic Effect) and side-effects (mainly increased random blood sugar levels)
Detailed description
Brachial plexus nerve blocks (BPBs) for upper extremity surgery provide superior analgesia and reduce opioid consumption. Supraclavicular block anesthetizes the brachial plexus where it is in its most compact form, thus providing a complete and reliable block for upper extremity surgery. Ultrasound guided single injection (SI) and triple injection (TI) techniques were found to provide the same degree of surgical anesthesia at 30 minutes while the TI technique needed more time to perform.
Many studies were conducted to examine the effect of perineural Dexamethasone as a local anesthetic adjuvant in low volume peripheral nerve blocks were it was found to increase the mean duration of analgesia (sensory block) with short, medium and long acting local anesthetics as well as the duration of motor blockade, with a reduction in pain scores at rest during the intermediate (8-12 h) and late (24 h) postoperative periods and in movement at all times. At 24 postoperative hours, cumulative morphine consumption and the rate of nausea or vomiting were also reduced without any reported related serious adverse effects, also the value of its concomitant intravenous use in prolonging the duration of analgesia after regional blocks was studied with promising results that can sometimes be compared to the perineural route but more short-lived and associated with higher increase in blood glucose levels. Dexamethasone's mechanism of action may result from decreased nociceptive C-fibre activity via a direct effect on glucocorticoid receptors and inhibitory effect on potassium channels.(8) Other authors suggest a local vasoconstrictive effect, resulting in reduced local anaesthetic absorption or a systemic anti-inflammatory effect following vascular uptake of the drug.
A debate exists whether perineural corticosteroids are harmful or not, but reports of neurotoxicity seem to be related mainly to the preservative benzyl alcohol and the vehicle polyethylene glycol found in some preparations, also may be related to the presence of insoluble steroid particulate matter in the injectate. Dexamethasone is non-particulate and can be found in a preservative-free formulation. In addition, no significant long-term electrophysiological, behavioural or histological effects for corticosteroids were identified on rat sciatic nerve tissue even some data suggest dexamethasone may actually be neuroprotective. In reality, perineural corticosteroid injections with and without preservative are widely used throughout the world.
Various doses of Dexamethasone were used in local anaesthetic mixtures in regional blocks in various studies, including 4, 5, 8 and 10 mg. In a recent review \& meta-analysis by E. Albrecht and his colleagues, sub-group analysis revealed no association between the total dose of perineural Dexamethasone and the mean increase in duration of analgesia showing that Dose-finding studies are needed to better define the optimal balance between dose, effects and side-effects, particularly at doses lower than 4 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The patients will be randomized to 4 groups: * Group A: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 0.5ml (2mg) Dexamethasone, 1.5ml Normal saline. * Group B: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 1ml (4mg) Dexamethasone, 1ml Normal saline. * Group C: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml (8mg) Dexamethasone. * Group Control: N-12 will receive a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml Normal saline.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: Ultrasound guided supraclavicular brachial plexus block, Drug: DexamethasoneN-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 0.5ml (2mg) Dexamethasone, 1.5ml Normal saline. |
| Group B | Active comparator | Procedure: Ultrasound guided supraclavicular brachial plexus block, Drug: DexamethasoneN-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 1ml (4mg) Dexamethasone, 1ml Normal saline. |
| Group C | Active comparator | Procedure: Ultrasound guided supraclavicular brachial plexus block, Drug: DexamethasoneN-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml (8mg) Dexamethasone. |
| Group Control | Active comparator | Procedure: Ultrasound guided supraclavicular brachial plexus blockN-12 Ultrasound guided supraclavicular brachial plexus block will be preformed using a total volume solution of 20ml: 18ml Bupivacaine 0.5%, 2ml Normal saline. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing surgeries in the upper limb (arm, forearm or hand)
Key exclusion criteria (9 listed)
- Coagulopathies (with prothrombin concentration less than 60% or INR more than 1.5)
- In-ability to postpone anti-coagulation medications.
- Infection or injury or a lesion at the block site.
- Suspected cervical vertebral column injury necessitating using a neck collar.
- A compromised lung on the contralateral side of the block (Pneumothorax, hemothorax or Pneumonectomy).
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 supraclavicular brachial plexus blockultrasound guided Supraclavicular brachial plexus block | Procedure or surgery | Group A, Group B, Group C, Group Control |
| DexamethasoneAlso: DecadronVarious doses of Dexamethasone (2, 4 \& 8 mg) to be used as an Adjuvant to Local anesthetic drugs | Drug | Group A, Group B, Group C |
Primary outcome
Duration of analgesia
Time frame: 24 hours
The time between injection of Local anesthetic mixture during performing the block and time of administration of the first dose of rescue analgesia at VAS equal or more than 4
5 secondary outcomes
Duration of motor block
Time frame: 24 hours
Patient Satisfaction score
Time frame: 24 hours
Random Blood glucose levels
Time frame: 24 hours
Incidence of PONV
Time frame: 24 hours
Incidence of complications
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Background: PubMed 20565394Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
- Background: PubMed 12132064Neal JM, Hebl JR, Gerancher JC, Hogan QH. Brachial plexus anesthesia: essentials of our current understanding. Reg Anesth Pain Med. 2002 Jul-Aug;27(4):402-28. doi: 10.1053/rapm.2002.34377. No abstract available.
- Background: PubMed 24348284Al Harbi M, Kaki AM, Kamal A, El-Dawlatly A, Daghistani M, El Tahan MR. A survey of the practice of regional anesthesia in Saudi Arabia. Saudi J Anaesth. 2013 Oct;7(4):367-70. doi: 10.4103/1658-354X.121041.
- Background: PubMed 26899862Rosenfeld DM, Ivancic MG, Hattrup SJ, Renfree KJ, Watkins AR, Hentz JG, Gorlin AW, Spiro JA, Trentman TL. Perineural versus intravenous dexamethasone as adjuncts to local anaesthetic brachial plexus block for shoulder surgery. Anaesthesia. 2016 Apr;71(4):380-8. doi: 10.1111/anae.13409. Epub 2016 Feb 22.
- Background: PubMed 23587875Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15.
- Results publication: PubMed 25123271Albrecht E, Kern C, Kirkham KR. A systematic review and meta-analysis of perineural dexamethasone for peripheral nerve blocks. Anaesthesia. 2015 Jan;70(1):71-83. doi: 10.1111/anae.12823. Epub 2014 Aug 14.
- Individual participant dataSharing planned: No
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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.
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 Ultrasound guided supraclavicular brachial plexus block and Dexamethasone in people with Dexamethasone and Supraclavicular Brachial Plexus Block, run by Eslam Ayman Mohamed Shawki 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 9 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: status not confirmed, as of the sponsor's last update on 6 Feb 2017. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eslam A Shawki, M.D. (+201225771017, eslam.ayman@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of analgesia (time frame: 24 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 NCT03043495, which also lists 6 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 Feb 2017.