Diseases of Mitral ValvePhase 4NCT01536717
Comparison of the Local Anaesthetics Articaine and Bupivacaine in Treatment of Acute Sternum Pain After Heart Surgery
A Phase 4 study testing Articaine hydrochloride 2% solution and Sodium Chloride in people with Diseases of Mitral Valve and Aortic Valve Disorder, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
The purpose of this study is to examine the wound infusion of articaine for treatment of acute post-sternotomy pain in a placebo-controlled manner using a prospective and randomized design and an active control (bupivacaine) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diseases of Mitral Valve, Aortic Valve Disorder, Atrial Septal Defects
- What is being tested?
- Articaine hydrochloride 2% solution and Sodium Chloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesFinland
- Study dates
- Mar 2012to Dec 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective procedure
- open heart surgery
- aortic valve surgery
- mitral valve surgery
- atrial septal defect repair surgery
- intracardial myxoma removal surgery
Who cannot join
- local anesthetic allergy
- sulphide allergy
- asthma
- pregnant women
- neurological disease (TIA excluded)
- congestive heart failure
Show all 12Show fewer
- left ventricle ejection fracture under 0.3
- liver failure
- diabetes mellitus with documented polyneuropathy
- chronic pain condition
- mother tongue not finnish or swedish
- patients, who do not agree blood transfusions
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Department of Anesthesiology and Intensive care medicine, Divison of Surgery, Meilahti hospital, Helsinki University Central Hospital
Helsinki, Uusimaa, 00029
Department of Cardiothoracic surgery, Division of Surgery, Meilahti hospital, Helsinki University Central Hospital
Helsinki, Uusimaa, 00029
About this study
Official title: Comparison of Periosteal and Subcutaneous Infusions of Articaine and Bupivacaine in Treatment of Acute Pain After Sternotomy
The purpose of this study is to examine the wound infusion of articaine for treatment of acute post-sternotomy pain in a placebo-controlled manner using a prospective and randomized design and an active control (bupivacaine)
Read the detailed description
Acute pain after open heart surgery can be moderate or strong and is mostly caused by sternotomy. Pain is the worst during the first two post-operative days and, if not adequately treated, can delay the patient´s recovery from surgery. Sternotomy pain can be alleviated by using paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. All these drugs may have remarkable side-effects which may delay the recovery from surgery: opioids are respiratory depressants and slower the gastrointestinal motility, NSAIDs reduce intrarenal blood flow and may disturb coagulation. Post-operative opioid consumption can be reduced by using wound infiltration analgesia.
The use of wound infiltration analgesia has not been extensively investigated in treatment of acute pain after sternotomy. There is some evidence, that 0.5% bupivacaine reduces the acute post-sternotomy pain when infused constantly via catheters placed under the fascia (periosteal placement) and the skin.
During 48 hours infusion toxic bupivacaine plasma levels were not observed. There is an evidence that local anesthetics can be bacteriostatic both in vitro and in vivo.
Articaine is an amide-type local anesthetics, which has been used extensively in dental procedures since more than forty years. It has been successfully used in infiltration, epidural, spinal and other regional anesthesia procedures. Articaine is quickly hydrolyzed in plasma and excreted by kidneys. Clearance of articain (500-1110l/h) is faster than that of lidocaine (68l/h) and it is also the reason for articaine´s low toxicity profile. Because of it´s low toxicity and high ability to penetrate the periosteal tissue, articaine may be advantageous in treatment of acute pain after sternotomy, but aforementioned indication for use of articaine has not been investigated. Compared to other local anesthetics, articaine in high concentration has the same neurotoxicity profile, when injected directly into rat´s sciatic nerve. Articaine has not been extensively compared to other local anesthetics, but according the latest odontologic investigation, single dose 0.5% bupivacaine and single-dose 4% articaine were comparable in their analgesic effects during tooth extraction procedure. There are no controlled randomized trials comparing analgesic effect of articaine and other local anesthetics infusions.
In our investigation bupivacain 0.5 % was chosen as an active control, because it has appeared effective in acute postoperative pain and it has reduced the need for opioid analgetics after sternotomy
- Conditions
- Diseases of Mitral Valve, Aortic Valve Disorder, Atrial Septal Defects, Intracardiac Myxoma
- Being tested
- Articaine hydrochloride 2% solution, Sodium Chloride
- Keywords
- atrial septal defect, mitral valve annuloplasty, aortic valve annuloplasty, open heart surgery, oxycodone consumption, articain, bupivacaine, pain after sternotomy, postoperative pain, wound infusion
- Medical subject headings
- Aortic Valve Disease, Heart Septal Defects, Atrial, Atrial myxoma, familial, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Articaine hydrochloride 2% solutionDrug
Also called Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08
- 4 ml/h periosteal wound infusion
- duration of 72 h
Sodium ChlorideDrug
Placebo Sodium chloride 0,9%
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine hydrochloride 0.5% | Active comparator | Bupivacaine hydrochloride is related chemically and pharmacologically to the aminoacyl local anesthetics. Bupivacaine hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures. Receives: Drug: Articaine hydrochloride 2% solution |
| Sodium chloride 0,9% | Placebo comparator | Not described Receives: Drug: Sodium Chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxycodone consumption
Measured: 72 hours from initiation of treatment
Secondary outcomes (1)
Intensity of pain in rest/in movement (AUC)
Measured: 72 hours from initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Diseases of Mitral ValveStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reino Poyhia, Helsinki University Central Hospital
- Investigators
- Reino Pöyhiä, MD, PhD, Study chair, Department of Anesthesiology and Intensive care, Division of Surgery, Meilahti Hospital, Helsinki University Central HospitalMihkel Meinberg, MD, Principal investigator, Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536717
- Sponsor's protocol ID
- 2011-004307-20
- Status last verified
- May 2019
- First submitted
- 16 Feb 2012
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kehlet H, Andersen LO. Local infiltration analgesia in joint replacement: the evidence and recommendations for clinical practice. Acta Anaesthesiol Scand. 2011 Aug;55(7):778-84. doi: 10.1111/j.1399-6576.2011.02429.x. Epub 2011 Apr 4.
PubMed 21463261White PF, Rawal S, Latham P, Markowitz S, Issioui T, Chi L, Dellaria S, Shi C, Morse L, Ing C. Use of a continuous local anesthetic infusion for pain management after median sternotomy. Anesthesiology. 2003 Oct;99(4):918-23. doi: 10.1097/00000542-200310000-00026.
PubMed 14508326Magnano D, Montalbano R, Lamarra M, Ferri F, Lorini L, Clarizia S, Rescigno G. Ineffectiveness of local wound anesthesia to reduce postoperative pain after median sternotomy. J Card Surg. 2005 Jul-Aug;20(4):314-8. doi: 10.1111/j.1540-8191.2005.200318.x.
PubMed 15985128Pere P, Lindgren L, Vaara M. Poor antibacterial effect of ropivacaine: comparison with bupivacaine. Anesthesiology. 1999 Sep;91(3):884-6. doi: 10.1097/00000542-199909000-00047. No abstract available.
PubMed 10485806Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. doi: 10.1016/j.bpa.2004.12.006.
PubMed 15966499Pelz K, Wiedmann-Al-Ahmad M, Bogdan C, Otten JE. Analysis of the antimicrobial activity of local anaesthetics used for dental analgesia. J Med Microbiol. 2008 Jan;57(Pt 1):88-94. doi: 10.1099/jmm.0.47339-0.
PubMed 18065672Vree TB, Baars AM, van Oss GE, Booij LH. High-performance liquid chromatography and preliminary pharmacokinetics of articaine and its 2-carboxy metabolite in human serum and urine. J Chromatogr. 1988 Feb 26;424(2):440-4. doi: 10.1016/s0378-4347(00)81126-3. No abstract available.
PubMed 3372637Brinklov MM. Clinical effects of carticaine, a new local anesthetic. A survey and a double-blind investigation comparing carticaine with lidocaine in epidural analgesia. Acta Anaesthesiol Scand. 1977;21(1):5-16. doi: 10.1111/j.1399-6576.1977.tb01186.x.
PubMed 320810Kallio H, Snall EV, Luode T, Rosenberg PH. Hyperbaric articaine for day-case spinal anaesthesia. Br J Anaesth. 2006 Nov;97(5):704-9. doi: 10.1093/bja/ael222. Epub 2006 Aug 5.
PubMed 16891634Pitkanen MT, Xu M, Haasio J, Rosenberg PH. Comparison of 0.5% articaine and 0.5% prilocaine in intravenous regional anesthesia of the arm: a cross-over study in volunteers. Reg Anesth Pain Med. 1999 Mar-Apr;24(2):131-5.
PubMed 10204898Simon MA, Vree TB, Gielen MJ, Booij LH, Lagerwerf AJ. Similar motor block effects with different disposition kinetics between lidocaine and (+ or -) articaine in patients undergoing axillary brachial plexus block during day case surgery. Int J Clin Pharmacol Ther. 1999 Dec;37(12):598-607.
PubMed 10599952Trullenque-Eriksson A, Guisado-Moya B. Comparative study of two local anesthetics in the surgical extraction of mandibular third molars: bupivacaine and articaine. Med Oral Patol Oral Cir Bucal. 2011 May 1;16(3):e390-6. doi: 10.4317/medoral.16.e390.
PubMed 21196829Pesonen A, Suojaranta-Ylinen R, Hammaren E, Kontinen VK, Raivio P, Tarkkila P, Rosenberg PH. Pregabalin has an opioid-sparing effect in elderly patients after cardiac surgery: a randomized placebo-controlled trial. Br J Anaesth. 2011 Jun;106(6):873-81. doi: 10.1093/bja/aer083. Epub 2011 Apr 6.
PubMed 21474474Hillerup S, Bakke M, Larsen JO, Thomsen CE, Gerds TA. Concentration-dependent neurotoxicity of articaine: an electrophysiological and stereological study of the rat sciatic nerve. Anesth Analg. 2011 Jun;112(6):1330-8. doi: 10.1213/ANE.0b013e3182172a2e. Epub 2011 Apr 5.
PubMed 21467556Tirotta CF, Munro HM, Salvaggio J, Madril D, Felix DE, Rusinowski L, Tyler C, Decampli W, Hannan RL, Burke RP. Continuous incisional infusion of local anesthetic in pediatric patients following open heart surgery. Paediatr Anaesth. 2009 Jun;19(6):571-6. doi: 10.1111/j.1460-9592.2009.03009.x.
PubMed 19645974
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Periosteal and Subcutaneous Infusions of Articaine and Bupivacaine in Treatment of Acute Pain After Sternotomy
- ClinicalTrials.gov ID
- NCT01536717
- Acronym / sponsor ID
- 2011-004307-20
- Conditions
- Diseases of Mitral Valve, Aortic Valve Disorder, Atrial Septal Defects, Intracardiac Myxoma
- Keywords
- atrial septal defect, mitral valve annuloplasty, aortic valve annuloplasty, open heart surgery, oxycodone consumption, articain, bupivacaine, pain after sternotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 22 Feb 2012 (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.
The purpose of this study is to examine the wound infusion of articaine for treatment of acute post-sternotomy pain in a placebo-controlled manner using a prospective and randomized design and an active control (bupivacaine)
Detailed description
Acute pain after open heart surgery can be moderate or strong and is mostly caused by sternotomy. Pain is the worst during the first two post-operative days and, if not adequately treated, can delay the patient´s recovery from surgery. Sternotomy pain can be alleviated by using paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. All these drugs may have remarkable side-effects which may delay the recovery from surgery: opioids are respiratory depressants and slower the gastrointestinal motility, NSAIDs reduce intrarenal blood flow and may disturb coagulation. Post-operative opioid consumption can be reduced by using wound infiltration analgesia.
The use of wound infiltration analgesia has not been extensively investigated in treatment of acute pain after sternotomy. There is some evidence, that 0.5% bupivacaine reduces the acute post-sternotomy pain when infused constantly via catheters placed under the fascia (periosteal placement) and the skin.
During 48 hours infusion toxic bupivacaine plasma levels were not observed. There is an evidence that local anesthetics can be bacteriostatic both in vitro and in vivo.
Articaine is an amide-type local anesthetics, which has been used extensively in dental procedures since more than forty years. It has been successfully used in infiltration, epidural, spinal and other regional anesthesia procedures. Articaine is quickly hydrolyzed in plasma and excreted by kidneys. Clearance of articain (500-1110l/h) is faster than that of lidocaine (68l/h) and it is also the reason for articaine´s low toxicity profile. Because of it´s low toxicity and high ability to penetrate the periosteal tissue, articaine may be advantageous in treatment of acute pain after sternotomy, but aforementioned indication for use of articaine has not been investigated. Compared to other local anesthetics, articaine in high concentration has the same neurotoxicity profile, when injected directly into rat´s sciatic nerve. Articaine has not been extensively compared to other local anesthetics, but according the latest odontologic investigation, single dose 0.5% bupivacaine and single-dose 4% articaine were comparable in their analgesic effects during tooth extraction procedure. There are no controlled randomized trials comparing analgesic effect of articaine and other local anesthetics infusions.
In our investigation bupivacain 0.5 % was chosen as an active control, because it has appeared effective in acute postoperative pain and it has reduced the need for opioid analgetics after sternotomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine hydrochloride 0.5% | Active comparator | Drug: Articaine hydrochloride 2% solutionBupivacaine hydrochloride is related chemically and pharmacologically to the aminoacyl local anesthetics. Bupivacaine hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures. |
| Sodium chloride 0,9% | Placebo comparator | Drug: Sodium Chloride |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- elective procedure
- open heart surgery
- aortic valve surgery
- mitral valve surgery
- atrial septal defect repair surgery
Key exclusion criteria (12 listed)
- local anesthetic allergy
- sulphide allergy
- asthma
- pregnant women
- neurological disease (TIA excluded)
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 |
|---|---|---|
| Articaine hydrochloride 2% solutionAlso: Ultracain D ohne Adrenalin 20 mg/ml, ATC code N01BB08* 4 ml/h periosteal wound infusion * duration of 72 h | Drug | Bupivacaine hydrochloride 0.5% |
| Sodium ChloridePlacebo Sodium chloride 0,9% | Drug | Sodium chloride 0,9% |
Primary outcome
Oxycodone consumption
Time frame: 72 hours from initiation of treatment
1 secondary outcome
Intensity of pain in rest/in movement (AUC)
Time frame: 72 hours from initiation of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Background: PubMed 21463261Kehlet H, Andersen LO. Local infiltration analgesia in joint replacement: the evidence and recommendations for clinical practice. Acta Anaesthesiol Scand. 2011 Aug;55(7):778-84. doi: 10.1111/j.1399-6576.2011.02429.x. Epub 2011 Apr 4.
- Background: PubMed 14508326White PF, Rawal S, Latham P, Markowitz S, Issioui T, Chi L, Dellaria S, Shi C, Morse L, Ing C. Use of a continuous local anesthetic infusion for pain management after median sternotomy. Anesthesiology. 2003 Oct;99(4):918-23. doi: 10.1097/00000542-200310000-00026.
- Background: PubMed 15985128Magnano D, Montalbano R, Lamarra M, Ferri F, Lorini L, Clarizia S, Rescigno G. Ineffectiveness of local wound anesthesia to reduce postoperative pain after median sternotomy. J Card Surg. 2005 Jul-Aug;20(4):314-8. doi: 10.1111/j.1540-8191.2005.200318.x.
- Background: PubMed 10485806Pere P, Lindgren L, Vaara M. Poor antibacterial effect of ropivacaine: comparison with bupivacaine. Anesthesiology. 1999 Sep;91(3):884-6. doi: 10.1097/00000542-199909000-00047. No abstract available.
- Background: PubMed 15966499Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. doi: 10.1016/j.bpa.2004.12.006.
- Background: PubMed 18065672Pelz K, Wiedmann-Al-Ahmad M, Bogdan C, Otten JE. Analysis of the antimicrobial activity of local anaesthetics used for dental analgesia. J Med Microbiol. 2008 Jan;57(Pt 1):88-94. doi: 10.1099/jmm.0.47339-0.
- Background: PubMed 3372637Vree TB, Baars AM, van Oss GE, Booij LH. High-performance liquid chromatography and preliminary pharmacokinetics of articaine and its 2-carboxy metabolite in human serum and urine. J Chromatogr. 1988 Feb 26;424(2):440-4. doi: 10.1016/s0378-4347(00)81126-3. No abstract available.
- Background: PubMed 320810Brinklov MM. Clinical effects of carticaine, a new local anesthetic. A survey and a double-blind investigation comparing carticaine with lidocaine in epidural analgesia. Acta Anaesthesiol Scand. 1977;21(1):5-16. doi: 10.1111/j.1399-6576.1977.tb01186.x.
- Background: PubMed 16891634Kallio H, Snall EV, Luode T, Rosenberg PH. Hyperbaric articaine for day-case spinal anaesthesia. Br J Anaesth. 2006 Nov;97(5):704-9. doi: 10.1093/bja/ael222. Epub 2006 Aug 5.
- Background: PubMed 10204898Pitkanen MT, Xu M, Haasio J, Rosenberg PH. Comparison of 0.5% articaine and 0.5% prilocaine in intravenous regional anesthesia of the arm: a cross-over study in volunteers. Reg Anesth Pain Med. 1999 Mar-Apr;24(2):131-5.
- Background: PubMed 10599952Simon MA, Vree TB, Gielen MJ, Booij LH, Lagerwerf AJ. Similar motor block effects with different disposition kinetics between lidocaine and (+ or -) articaine in patients undergoing axillary brachial plexus block during day case surgery. Int J Clin Pharmacol Ther. 1999 Dec;37(12):598-607.
- Background: PubMed 21196829Trullenque-Eriksson A, Guisado-Moya B. Comparative study of two local anesthetics in the surgical extraction of mandibular third molars: bupivacaine and articaine. Med Oral Patol Oral Cir Bucal. 2011 May 1;16(3):e390-6. doi: 10.4317/medoral.16.e390.
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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.
Reino Pöyhiä, MD, PhD study chair
Department of Anesthesiology and Intensive care, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
Mihkel Meinberg, MD principal investigator
Department of Anesthesiology and Intensive care medicine, Division of Surgery, Meilahti Hospital, Helsinki University Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Articaine hydrochloride 2% solution and Sodium Chloride in people with Diseases of Mitral Valve and Aortic Valve Disorder, run by Helsinki University Central Hospital at 2 sites in Finland.
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 6 inclusion and 12 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: paused, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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. Some participants in this study may receive a placebo. 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?
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?
Oxycodone consumption (time frame: 72 hours from initiation of treatment). 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 NCT01536717, which also lists 20 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 7 May 2019.