Blood Coagulation DisordersAGINRNCT01930916
Accuracy of a Portable International Normalized Ratio Monitor in Elderly Patients
A study testing INR capillary measurement with INRatio 2 device and antiphospholipid antibodies and lupus anticoagulant in people with Blood Coagulation Disorders and Blood Coagulation Disorder With Prolonged Bleeding Time, run by University Hospital, Caen at 4 sites in France.
Trial summary
Oral anticoagulants vitamin K antagonists (VKA) have been used for many years in the treatment of thromboembolic disorders, which are among the most costly diseases in terms of public health resources. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Blood Coagulation Disorders, Blood Coagulation Disorder With Prolonged Bleeding Time, Blood Coagulation Disorder With Prolonged Coagulation Time
- What is being tested?
- INR capillary measurement with INRatio 2 device and antiphospholipid antibodies and lupus anticoagulant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2012to Dec 2014
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient over 75 years
- Recipient of the social security system
- Patient receiving anti vitamin K treatment
- Hospitalized in Internal Medicine, Geriatrics, Vascular Medicine
- Having signed an informed consent to participate in the study
Who cannot join
- Contraindication to a digital sampling.
- Conditions preventing the realization of INRatio2 ® test : Amputation of the extremities, trophic disorders of the extremities.
- Concomitant use of heparin.
- Mental or physical illness which do not permit to consent to participate in the study
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Not yet recruiting
Centre hospitalier régional universitaire d'Amiens
Amiens, 80054
Marie-Antoinette Sevestre, M.D,Ph.D, + 33 3 22 45 59 30, sevestre.marie-antoinette@chu-amiens.fr
Marie-antoinette Sevestre, M.D, Ph.D
- Recruiting
Centre hospitalier régional universitaire de Caen
Caen, 14000
Boris Bienvenu, M.D,Ph.D, +33 (0)2 31 06 45 84, bienvenu-b@chu-caen.fr
boris bienvenu, M.D,Ph.D
- Not yet recruiting
Centre hospitalier régional universitaire de Lille
Lille, 59000
Marc Lambert, M.D,Ph.D, +33 3 20 44 42 96, marc.lambert@chru-lille.fr
marc lambert, M.D,Ph.D
- Not yet recruiting
Centre hospitalier régional universitaire de Rouen
Rouen, 76000
Ygal Benhamou, M.D, ygal.benhamou@chu-rouen.fr
Ygal Benhamou, M.D
About this study
Official title: Accuracy of a Portable International Normalized Ratio Monitor in a Population Aged 75 Years Old and Over
Oral anticoagulants vitamin K antagonists (VKA) have been used for many years in the treatment of thromboembolic disorders, which are among the most costly diseases in terms of public health resources. According to the Agence française de sécurité sanitaire des produits de santé (AFSSAPS), it was estimated at about 900,000 the number of patients treated with VKA in 2008 (more than 1% of the French population). VKA are at the origin of many adverse effects, given their narrow therapeutic window. They are the cause of the death of approximately 5000 patients per year. The use of this therapy is a priority axis of reflection for the Haute Autorité de Santé.
The interregion G4 (Nord Pas de Calais, Normandy, Picardy), with more than 9 million people, is particularly affected by this problem.
Read more
University hospitals of our interregion, given their very substantial regional referral activity, are actually involved in managing VKA adverse side effects.
Elderly population constitutes the majority of prescriptions. The main objective of this study is to compare INR of people older than 75 years measured by traditional method with those measured by capillary method with INRatio2 supply.
The secondary objective is to show that this measure is not affected by the presence or absence of anti-phospholipid antibodies, probably very prevalent in the elderly, as well as to test the variability of INR measurement between different hospital.
Read the detailed description
Adverse effects of oral anticoagulants (warfarin, fluindione mainly) are bleeding complications and concern 13% of hospitalizations, approximately 17,000 admissions per year. They constitute 12.3% of iatrogenic adverse effect according to the latest results of the survey conducted by the haute autorité de santé (HAS). A study realized in 2000, with 2976 patients, shows that 28.8% of patients were outside of any therapeutic range (<2 or> 4.5). In 2003, a third of french biologists had no knowledge of the indication of VKA treatment of patients at the INR measurement, and more than fifty percent in 2000. When the therapeutic range was known, the value of the INR remained outside it in 30% of cases. The median time between INR equilibration phase was 5 to 6 days, while the recommended time is 2 to 4 days. A quarter of patients in phase equilibrium treatment did not have a measure of INR at least once a month. Followed over a period of a year, patients spent 40% of the time with a value of INR outside the therapeutic range, high-risk area of recurrent thrombosis or hemorrhage. That is why they require regular monitoring of INR.
Currently, this monitoring is done through a blood sample analyzed by a laboratory according to standard techniques.
The use of the INR measurement by capillary method provides a result in less than 3 minutes. This also allows the development of different monitoring strategies. In the context of a self-monitoring measure, the patient himself performs the test using the device and therapeutic adjustment is made by the health care professional.
Data analysis by HAS showed that the use of a self-measurement device significantly improved the time spent in the therapeutic range, reduced the risk of major bleeding and the accident major thromboembolism.
The pathologies treated by VKA are more common in the elderly. They are also more vulnerable to falls, overdoses of these treatments because their pharmacokinetics is amended by polypharmacy, malnutrition, less protein binding. The relative risk of bleeding is multiplicated by two beyond 70 years. Despite the emergence of new anticoagulants in the prevention of complications of arrhythmia (this disorder affect nearly 10% of the population aged over 80 years), VKA remains prevalent because these new drugs have renal elimination that can not be monitored, and can not be dialysable, have no antidote and represent a daily cost about 30 times the VKA.
The question of the use of devices for self-measurement of INR in the elderly is particularly timely, because this population has never had, to our knowledge, a specific evaluation of this technique.
Elderly population would derive the greatest benefit of this system because it will significantly improve the time spend in the therapeutic range, and reduce the risk of bleeding and thromboembolic events in reducing INR fluctuations.
We build a multicenter study whose main objective is to demonstrate the concordance of INR measurement by the capillary way (INRatio2 ®, SAS ALERE, Jouy-en-Josas) with venous technical reference. It concerns patients older than 75 years treated with VKA and hospitalized in Internal Medicine, Geriatrics and Vascular Medicine in the fours university hospital of the G4 region. The secondary objectives are to estimate the prevalence of antiphospholipid antibodies (ranging from 12 to 55% depending on the study) and their influence on the measurement of the INR by capillary method and the variability of the INR veinous measurement in function of the hospital, with a centralized INR measurement which allow to compare. 150 patients is required to perform this study.
- Conditions
- Blood Coagulation Disorders, Blood Coagulation Disorder With Prolonged Bleeding Time, Blood Coagulation Disorder With Prolonged Coagulation Time
- Being tested
- INR capillary measurement with INRatio 2 device, antiphospholipid antibodies and lupus anticoagulant
- Keywords
- Prothrombin Time/instrumentation, Prothrombin Time/utilization, Blood Coagulation Disorders/blood, Blood Coagulation Disorders/complications, Blood Coagulation Disorders/diagnosis, Prospective Studies, Adult, Reproducibility of Results, Point-of-Care Systems/utilization, Aged, Elderly
- Medical subject headings
- Blood Coagulation Disorders, Disease, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INR capillary measurement with INRatio 2 deviceDevice
INR capillary measurement with INRatio 2 device
antiphospholipid antibodies and lupus anticoagulantOther
Rate of antiphospholipid antibodies and lupus anticoagulant dosage A 5ml blood sample obtained by veinous punction.
| Study group | Role | What they receive |
|---|---|---|
| Not interventionnal | Other | INR capillary measurement with INRatio 2 device antiphospholipid antibodies and lupus anticoagulant Receives: Device: INR capillary measurement with INRatio 2 device; Other: antiphospholipid antibodies and lupus anticoagulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
INR by capillary method and INR by veinous punction
INR by the classical way (punction) and comparison with a capillary method tested here.
INR by capillary method is done immediately after inclusion. INR by veinous punction is done on the 24 hours after the inclusion.
Measured: 24 hours
Secondary outcomes (1)
Difference between International normalized ratio (INR) measured in a veinous blood punction and with a capillary method on the same patient and correlated to the level of phospholipid antibodies and lupus anti coagulant
We want to know if the level of lupus and anti cardiolipin antibodies influence the value of INR measured by capillary method.
lupus and anti cardiolipin antibodies tubes will be frozen after punction and analysed up to 1 year after.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startOct 2012
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (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 Blood Coagulation DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris Bienvenu, M.D,Ph.D, Principal investigator, Centre hospitalier régional universitaire de CaenJean Jacques Dutheil, Study director, Centre hospitalier régional universitaire de CaenLaurent Auboire, M.D, Study chair, Centre hospitalier régional universitaire de Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01930916
- Sponsor's protocol ID
- 2012-A00586-37
- Acronym
- AGINR
- Status last verified
- Apr 2014
- First submitted
- 16 Nov 2012
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manoussakis MN, Tzioufas AG, Silis MP, Pange PJ, Goudevenos J, Moutsopoulos HM. High prevalence of anti-cardiolipin and other autoantibodies in a healthy elderly population. Clin Exp Immunol. 1987 Sep;69(3):557-65.
PubMed 3499270Stewart S, Hart CL, Hole DJ, McMurray JJ. Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart. 2001 Nov;86(5):516-21. doi: 10.1136/heart.86.5.516.
PubMed 11602543Bazzan M, Montaruli B, Vaccarino A, Fornari G, Saitta M, Prandoni P. Presence of low titre of antiphospholipid antibodies in cancer patients: a prospective study. Intern Emerg Med. 2009 Dec;4(6):491-5. doi: 10.1007/s11739-009-0316-6. Epub 2009 Sep 26.
PubMed 19784751Sene D, Piette JC, Cacoub P. Antiphospholipid antibodies, antiphospholipid syndrome and infections. Autoimmun Rev. 2008 Feb;7(4):272-7. doi: 10.1016/j.autrev.2007.10.001. Epub 2007 Oct 23.
PubMed 18295729Quemeneur T, Lambert M, Hachulla E, Dubucquoi S, Caron C, Fauchais AL, Devulder B, Hatron PY. Significance of persistent antiphospholipid antibodies in the elderly. J Rheumatol. 2006 Aug;33(8):1559-62.
PubMed 16832847Perry SL, Samsa GP, Ortel TL. Point-of-care testing of the international normalized ratio in patients with antiphospholipid antibodies. Thromb Haemost. 2005 Dec;94(6):1196-202. doi: 10.1160/TH05-06-0400.
PubMed 16411394
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of a Portable International Normalized Ratio Monitor in a Population Aged 75 Years Old and Over
- ClinicalTrials.gov ID
- NCT01930916
- Acronym / sponsor ID
- AGINR / 2012-A00586-37
- Conditions
- Blood Coagulation Disorders, Blood Coagulation Disorder With Prolonged Bleeding Time, Blood Coagulation Disorder With Prolonged Coagulation Time
- Keywords
- Prothrombin Time/instrumentation, Prothrombin Time/utilization, Blood Coagulation Disorders/blood, Blood Coagulation Disorders/complications, Blood Coagulation Disorders/diagnosis, Prospective Studies, Adult, Reproducibility of Results
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 29 Aug 2013 (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.
Oral anticoagulants vitamin K antagonists (VKA) have been used for many years in the treatment of thromboembolic disorders, which are among the most costly diseases in terms of public health resources. According to the Agence française de sécurité sanitaire des produits de santé (AFSSAPS), it was estimated at about 900,000 the number of patients treated with VKA in 2008 (more than 1% of the French population). VKA are at the origin of many adverse effects, given their narrow therapeutic window. They are the cause of the death of approximately 5000 patients per year. The use of this therapy is a priority axis of reflection for the Haute Autorité de Santé.
The interregion G4 (Nord Pas de Calais, Normandy, Picardy), with more than 9 million people, is particularly affected by this problem.
University hospitals of our interregion, given their very substantial regional referral activity, are actually involved in managing VKA adverse side effects.
Elderly population constitutes the majority of prescriptions. The main objective of this study is to compare INR of people older than 75 years measured by traditional method with those measured by capillary method with INRatio2 supply.
The secondary objective is to show that this measure is not affected by the presence or absence of anti-phospholipid antibodies, probably very prevalent in the elderly, as well as to test the variability of INR measurement between different hospital.
Detailed description
Adverse effects of oral anticoagulants (warfarin, fluindione mainly) are bleeding complications and concern 13% of hospitalizations, approximately 17,000 admissions per year. They constitute 12.3% of iatrogenic adverse effect according to the latest results of the survey conducted by the haute autorité de santé (HAS). A study realized in 2000, with 2976 patients, shows that 28.8% of patients were outside of any therapeutic range (<2 or> 4.5). In 2003, a third of french biologists had no knowledge of the indication of VKA treatment of patients at the INR measurement, and more than fifty percent in 2000. When the therapeutic range was known, the value of the INR remained outside it in 30% of cases. The median time between INR equilibration phase was 5 to 6 days, while the recommended time is 2 to 4 days. A quarter of patients in phase equilibrium treatment did not have a measure of INR at least once a month. Followed over a period of a year, patients spent 40% of the time with a value of INR outside the therapeutic range, high-risk area of recurrent thrombosis or hemorrhage. That is why they require regular monitoring of INR.
Currently, this monitoring is done through a blood sample analyzed by a laboratory according to standard techniques.
The use of the INR measurement by capillary method provides a result in less than 3 minutes. This also allows the development of different monitoring strategies. In the context of a self-monitoring measure, the patient himself performs the test using the device and therapeutic adjustment is made by the health care professional.
Data analysis by HAS showed that the use of a self-measurement device significantly improved the time spent in the therapeutic range, reduced the risk of major bleeding and the accident major thromboembolism.
The pathologies treated by VKA are more common in the elderly. They are also more vulnerable to falls, overdoses of these treatments because their pharmacokinetics is amended by polypharmacy, malnutrition, less protein binding. The relative risk of bleeding is multiplicated by two beyond 70 years. Despite the emergence of new anticoagulants in the prevention of complications of arrhythmia (this disorder affect nearly 10% of the population aged over 80 years), VKA remains prevalent because these new drugs have renal elimination that can not be monitored, and can not be dialysable, have no antidote and represent a daily cost about 30 times the VKA.
The question of the use of devices for self-measurement of INR in the elderly is particularly timely, because this population has never had, to our knowledge, a specific evaluation of this technique.
Elderly population would derive the greatest benefit of this system because it will significantly improve the time spend in the therapeutic range, and reduce the risk of bleeding and thromboembolic events in reducing INR fluctuations.
We build a multicenter study whose main objective is to demonstrate the concordance of INR measurement by the capillary way (INRatio2 ®, SAS ALERE, Jouy-en-Josas) with venous technical reference. It concerns patients older than 75 years treated with VKA and hospitalized in Internal Medicine, Geriatrics and Vascular Medicine in the fours university hospital of the G4 region. The secondary objectives are to estimate the prevalence of antiphospholipid antibodies (ranging from 12 to 55% depending on the study) and their influence on the measurement of the INR by capillary method and the variability of the INR veinous measurement in function of the hospital, with a centralized INR measurement which allow to compare. 150 patients is required to perform this study.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Not interventionnal | Other | Device: INR capillary measurement with INRatio 2 device, Other: antiphospholipid antibodies and lupus anticoagulantINR capillary measurement with INRatio 2 device antiphospholipid antibodies and lupus anticoagulant |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patient over 75 years
- Recipient of the social security system
- Patient receiving anti vitamin K treatment
- Hospitalized in Internal Medicine, Geriatrics, Vascular Medicine
- Having signed an informed consent to participate in the study
Key exclusion criteria (4 listed)
- Contraindication to a digital sampling.
- Conditions preventing the realization of INRatio2 ® test : Amputation of the extremities, trophic disorders of the extremities.
- Concomitant use of heparin.
- Mental or physical illness which do not permit to consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INR capillary measurement with INRatio 2 deviceINR capillary measurement with INRatio 2 device | Device | Not interventionnal |
| antiphospholipid antibodies and lupus anticoagulantRate of antiphospholipid antibodies and lupus anticoagulant dosage A 5ml blood sample obtained by veinous punction. | Other | Not interventionnal |
Primary outcome
INR by capillary method and INR by veinous punction
Time frame: 24 hours
INR by the classical way (punction) and comparison with a capillary method tested here. INR by capillary method is done immediately after inclusion. INR by veinous punction is done on the 24 hours after the inclusion.
1 secondary outcome
Difference between International normalized ratio (INR) measured in a veinous blood punction and with a capillary method on the same patient and correlated to the level of phospholipid antibodies and lupus anti coagulant
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
- Background: PubMed 3499270Manoussakis MN, Tzioufas AG, Silis MP, Pange PJ, Goudevenos J, Moutsopoulos HM. High prevalence of anti-cardiolipin and other autoantibodies in a healthy elderly population. Clin Exp Immunol. 1987 Sep;69(3):557-65.
- Background: PubMed 11602543Stewart S, Hart CL, Hole DJ, McMurray JJ. Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart. 2001 Nov;86(5):516-21. doi: 10.1136/heart.86.5.516.
- Background: PubMed 19784751Bazzan M, Montaruli B, Vaccarino A, Fornari G, Saitta M, Prandoni P. Presence of low titre of antiphospholipid antibodies in cancer patients: a prospective study. Intern Emerg Med. 2009 Dec;4(6):491-5. doi: 10.1007/s11739-009-0316-6. Epub 2009 Sep 26.
- Background: PubMed 18295729Sene D, Piette JC, Cacoub P. Antiphospholipid antibodies, antiphospholipid syndrome and infections. Autoimmun Rev. 2008 Feb;7(4):272-7. doi: 10.1016/j.autrev.2007.10.001. Epub 2007 Oct 23.
- Background: PubMed 16832847Quemeneur T, Lambert M, Hachulla E, Dubucquoi S, Caron C, Fauchais AL, Devulder B, Hatron PY. Significance of persistent antiphospholipid antibodies in the elderly. J Rheumatol. 2006 Aug;33(8):1559-62.
- Background: PubMed 16411394Perry SL, Samsa GP, Ortel TL. Point-of-care testing of the international normalized ratio in patients with antiphospholipid antibodies. Thromb Haemost. 2005 Dec;94(6):1196-202. doi: 10.1160/TH05-06-0400.
Related trials for Blood Coagulation Disorders
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
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.
Boris Bienvenu, M.D,Ph.D principal investigator
Centre hospitalier régional universitaire de Caen
Jean Jacques Dutheil study director
Centre hospitalier régional universitaire de Caen
Laurent Auboire, M.D study chair
Centre hospitalier régional universitaire de Caen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INR capillary measurement with INRatio 2 device and antiphospholipid antibodies and lupus anticoagulant in people with Blood Coagulation Disorders and Blood Coagulation Disorder With Prolonged Bleeding Time, run by University Hospital, Caen at 4 sites in France.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Apr 2014. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boris Bienvenu, M.D, Ph.D (+33 (0)2 31 06 45 84, bienvenu-b@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INR by capillary method and INR by veinous punction (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 NCT01930916, 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 9 Apr 2014.