Fibrillation, AtrialPhase 2NCT00911300
Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm
A Phase 2 study testing fondaparinux, unfractionated heparin and Vitamin-K-Antagonist in people with Fibrillation, Atrial, run by GlaxoSmithKline at 34 sites in 2 countries.
Trial summary
The purpose of this study is to test whether Fondaparinux is effective and safe to prevent thromboembolic events (like for example strokes) and bleeding events in patients who undergo a normalisation of their heart rhythm disturbance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrillation, Atrial
- What is being tested?
- fondaparinux, unfractionated heparin and Vitamin-K-Antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Aug 2009to Sep 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged at least 18 years with atrial fibrillation (AF) meeting at least one of the following criteria (a, b, c): a. Acute clinical symptoms (like palpitations, chest pain, dyspnea, fatigue, lightheadedness, or syncope) for at least 48 hours and AF on baseline ECG b. Newly discovered AF persisting for >=7 days c. Recurrent AF persisting for >=7 days
Who cannot join
- No documented sinus rhythm on ECG for more than 1 year
- Acute neurological deficits (TIA, stroke, intracranial bleeding), or known disease which may cause neurological deficits (e.g., multiple sclerosis, seizure disorder)
- Treatment with antithrombotic agents, including low-dose anticoagulation, for more than 48 hours prior to randomisation
- Treatment with oral NSAIDs or ASA at doses greater than 325 mg per day for more than 72 hours prior to randomisation
- Anticoagulant therapy required or likely to be required during the study period
- Treatment with ASA at a dose greater than 325 mg per day or oral NSAIDs (at any dose) required or likely to be required during the study period
Show all 15Show fewer
- Treatment with two or more antiplatelet agents (e.g. clopidogrel and ASA) at any dose at the same time (i.e., within 24 hours)
- Known hypersensitivity to UFH, VKA, or Fondaparinux or one of these drugs' excipients
- Active, clinically significant bleeding or clinically significant bleeding within the past month
- Major surgery within the previous three months
- Uncontrolled arterial hypertension (persistent systolic blood pressure over 180 mm Hg or diastolic blood pressure over 110 mm Hg)
- Bacterial endocarditis
- Calculated creatinine clearance < 30 mL/min
- Body weight < 50 kg
- Planned surgery or intervention within the next 65 days
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
Germany20 sites
GSK Investigational Site
Aschaffenburg, Bavaria, 63739
GSK Investigational Site
Bad Tölz, Bavaria, 83646
GSK Investigational Site
Berlin, State of Berlin, 10249
GSK Investigational Site
Berlin, State of Berlin, 10405
GSK Investigational Site
Berlin, State of Berlin, 13353
GSK Investigational Site
Bielefeld, North Rhine-Westphalia, 33604
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53115
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53127
GSK Investigational Site
Duisburg-Huckingen, North Rhine-Westphalia, 47259
GSK Investigational Site
Frankfurt am Main, Hesse, 60488
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
GSK Investigational Site
Hagenow, Mecklenburg-Vorpommern, 19230
GSK Investigational Site
Kassel, Hesse, 34121
GSK Investigational Site
Kassel, Hesse, 34125
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39120
GSK Investigational Site
Pirna, Saxony, 01796
GSK Investigational Site
Potsdam, Brandenburg, 14467
GSK Investigational Site
Simbach A. Inn, Bavaria, 84359
GSK Investigational Site
Unna, North Rhine-Westphalia, 59423
GSK Investigational Site
Wesel, North Rhine-Westphalia, 46483
France14 sites
GSK Investigational Site
Albi, 81000
GSK Investigational Site
Antony, 92166
GSK Investigational Site
Brest, 29609
GSK Investigational Site
Créteil, 94000
GSK Investigational Site
Évecquemont, 78740
GSK Investigational Site
Montpellier, 34295
GSK Investigational Site
Paris, 75571
GSK Investigational Site
Paris, 75651
GSK Investigational Site
Pau, 64046
GSK Investigational Site
Pessac, 33604
GSK Investigational Site
Poitiers, 86021
GSK Investigational Site
Rennes, 35033
GSK Investigational Site
Toulouse, 31059
GSK Investigational Site
Toulouse, 31076
About this study
Official title: An International, Multicentre, Randomised, Open, Controlled, Two-parallel Group, Phase II Pilot Study to Evaluate the Efficacy and Safety of ARIXTRA™ for Anticoagulation of Patients With Atrial Fibrillation Undergoing Electric Cardioversion Following Transesophageal Echocardiography
The purpose of this study is to test whether Fondaparinux is effective and safe to prevent thromboembolic events (like for example strokes) and bleeding events in patients who undergo a normalisation of their heart rhythm disturbance. Fondaparinux will be compared with Heparin and tablets containing Vitamin-K-Antagonists (Phenprocoumon, Fluindione, or Warfarin).
- Conditions
- Fibrillation, Atrial
- Being tested
- fondaparinux, unfractionated heparin, Vitamin-K-Antagonist
- Keywords
- Cardioversion, Electric, Pathological Conditions, Sings and Symptoms, Cardiovascular Diseases, Heart Diseases, Atrial Fibrillation, Arrhythmias, Cardiac, Pathologic Processes, Anticoagulants
- Medical subject headings
- Atrial Fibrillation, Cardiovascular Diseases, Heart Diseases, Arrhythmias, Cardiac, Pathologic Processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fondaparinuxDrug
Comparison of different drugs
unfractionated heparinDrug
Comparison of different drugs
Vitamin-K-AntagonistDrug
Comparison of different drugs
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: fondaparinux | Active comparator | Not described Receives: Drug: fondaparinux |
| Arm 2: unfractionated heparin + Vitamin-K-Antagonist | Active comparator | Not described Receives: Drug: unfractionated heparin; Drug: Vitamin-K-Antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days
Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolization, e.g., Transient Ischemic Attack (TIA), cerebral infarction. The cerebrovascular origin of the event has to be confirmed by objective procedures. Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All cerebral neurologic events were adjudicated by a Central Adjudication Committee (CAC), members of which were unaware of the participants' treatment assignment.
Measured: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants
Secondary outcomes (9)
Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event
Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolisation, e.g., TIA, cerebral infarction. All cerebral neurologic events were adjudicated by a CAC, members of which were unaware of the participants' treatment assignment.The cerebrovascular origin of the event was confirmed by objective procedures. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).
Measured: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism
Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All systemic thromboembolic events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).
Measured: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause
The cause of death was classified as due to a thromboembolic event (like cerebral infarction), bleeding, or other established diagnosis, or as unexplained. All deaths were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors).
Measured: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event
Major bleeding: fatal, and/or symptomatic in a critical area/ organ, causes a fall in hemoglobin of >=3 grams/deciliter compared with the pre-randomization level, or leads to the transfusion of >=2 units of whole blood/red blood cells. All bleeding events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus/ blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets, and the activation of the humoral coagulation system (i.e., clotting factors).
Measured: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event
Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment.
Measured: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Number of Participants With Primary Successful Electrical Cardioversion (CV) in Sinus Rhythm
CV may be performed electively to restore sinus rhythm in patients with persistent AF. The primary successful electric CV was assessed by a 12- lead electrocardiogram (ECG) directly after the CV. Results of the last cardioversion were used in cases for which more than one CV was performed.
Measured: Day 1 until Day 3
Number of Participants With a Thrombus in the Left Atrium (LA) or in the Left Atrial Appendage (LAA) at the Time of the Second TEE
Atrial fibrillation (AF) causes stagnant blood in the LA or LAA and can lead to a thromboembolism. Stasis in the LAA represents the principal mechanism of thrombus formation in AF.
Measured: At second TEE (at Day 28+/-4)
Number of Thrombus-negative and Thrombus-positive Participants With Conversion to Sinus Rhythm
Sinus rhythm is the normal beating of the heart, as measured by an ECG. Normal sinus rhythm not only indicates that the rhythm is normally generated by the sinus node and is traveling in a normal fashion in the heart, but it also indicates that the heart rate (the rate at which the sinus node is generating impulses) is within normal limits.
Measured: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Day 64 until the follow-up visit (FU) (Day 90+/-7)
Number of Participants Who Were Re-hospitalized
Hospitalization signifies that the participant has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out-patient setting. Re-hospitalization refers to an event of hospitalization after discharge for the initial hospitilization for the cardioversion.
Measured: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fibrillation, AtrialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911300
- Sponsor's protocol ID
- 111418
- Status last verified
- Sep 2012
- First submitted
- 28 May 2009
- Last updated
- 1 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multicentre, Randomised, Open, Controlled, Two-parallel Group, Phase II Pilot Study to Evaluate the Efficacy and Safety of ARIXTRA™ for Anticoagulation of Patients With Atrial Fibrillation Undergoing Electric Cardioversion Following Transesophageal Echocardiography
- ClinicalTrials.gov ID
- NCT00911300
- Acronym / sponsor ID
- 111418
- Conditions
- Fibrillation, Atrial
- Keywords
- Cardioversion, Electric, Pathological Conditions, Sings and Symptoms, Cardiovascular Diseases, Heart Diseases, Atrial Fibrillation, Arrhythmias, Cardiac, Pathologic Processes, Anticoagulants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 1 Jun 2009 (estimated)
- Results
- Posted 5 Sep 2012
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 test whether Fondaparinux is effective and safe to prevent thromboembolic events (like for example strokes) and bleeding events in patients who undergo a normalisation of their heart rhythm disturbance. Fondaparinux will be compared with Heparin and tablets containing Vitamin-K-Antagonists (Phenprocoumon, Fluindione, or Warfarin).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: fondaparinux | Active comparator | Drug: fondaparinux |
| Arm 2: unfractionated heparin + Vitamin-K-Antagonist | Active comparator | Drug: unfractionated heparin, Drug: Vitamin-K-Antagonist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female patients aged at least 18 years with atrial fibrillation (AF) meeting at least one of the following criteria (a, b, c): a. Acute clinical symptoms (like palpitations, chest pain, dyspnea, fatigue, lightheadedness, or syncope) for at least 48 hours and AF on baseline ECG b. Newly discovered AF persisting for >=7 days c. Recurrent AF persisting for >=7 days
Key exclusion criteria (15 listed)
- No documented sinus rhythm on ECG for more than 1 year
- Acute neurological deficits (TIA, stroke, intracranial bleeding), or known disease which may cause neurological deficits (e.g., multiple sclerosis, seizure disorder)
- Treatment with antithrombotic agents, including low-dose anticoagulation, for more than 48 hours prior to randomisation
- Treatment with oral NSAIDs or ASA at doses greater than 325 mg per day for more than 72 hours prior to randomisation
- Anticoagulant therapy required or likely to be required during the study period
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 |
|---|---|---|
| fondaparinuxComparison of different drugs | Drug | Arm 1: fondaparinux |
| unfractionated heparinComparison of different drugs | Drug | Arm 2: unfractionated heparin + Vitamin-K-Antagonist |
| Vitamin-K-AntagonistComparison of different drugs | Drug | Arm 2: unfractionated heparin + Vitamin-K-Antagonist |
Primary outcome
Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days
Time frame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants
Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolization, e.g., Transient Ischemic Attack (TIA), cerebral infarction. The cerebrovascular origin of the event has to be confirmed by objective procedures. Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All cerebral neurologic events were adjudicated by a Central Adjudication Committee (CAC), members of which were unaware of the participants' treatment assignment.
9 secondary outcomes
Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event
Time frame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism
Time frame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause
Time frame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event
Time frame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event
Time frame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Number of Participants With Primary Successful Electrical Cardioversion (CV) in Sinus Rhythm
Time frame: Day 1 until Day 3
Number of Participants With a Thrombus in the Left Atrium (LA) or in the Left Atrial Appendage (LAA) at the Time of the Second TEE
Time frame: At second TEE (at Day 28+/-4)
Number of Thrombus-negative and Thrombus-positive Participants With Conversion to Sinus Rhythm
Time frame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Day 64 until the follow-up visit (FU) (Day 90+/-7)
Number of Participants Who Were Re-hospitalized
Time frame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fondaparinux, unfractionated heparin and Vitamin-K-Antagonist in people with Fibrillation, Atrial, run by GlaxoSmithKline at 34 sites in 2 countries.
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 15 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 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Germany, 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days (time frame: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants). 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 1 Oct 2012.