Chronic PeriodontitisPhase 2AMX-PerioNCT03354338
Amoxicillin to Prevent Bacteria and Inflammatory Biomarkers After Intensive Periodontal Therapy
A Phase 2 study testing Amoxicillin in people with Chronic Periodontitis and Bacteremia, run by Universidad El Bosque, Bogotá at 1 site in Colombia.
Trial summary
There are not published studies evaluating the incidence, nature, magnitude and/or duration of bacteremia after periodontal treatment. The pre-surgical antibiotics have been studied particullary over Gram positive bacterial but not over gram negative bacterial and their secondary effects over the systemic… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Bacteremia
- What is being tested?
- Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteColombia
- Study dates
- 21 Sep 2017to 31 Jul 2018
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with chronic periodontitis (Ameriacam Academy of Periodontology 2015), having at least 2 teeth for quadrant with periodontal probing pockets depth ≥ 5 mm.
Who cannot join
- Pregnant and lactating women, Diabetes, hypertension, Obesity, Allergy to penicillin, consumption of systemic antimicrobial or anti-inflamatory drugs in the last 2 months, Autoimmune diseases, patients with medical conditions that required antibiotic premedication such as prosthetic heart valve replacement, skeletal joint replacement, previous history of infective endocarditis and history of rheumatic fever.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intensive Periodontal Therapy and Premedication With Oral Amoxicilline on Inflammatory Markers and Bacteremia in Patients With Chronic Periodontitis. A Randomized Controlled Trial.
There are not published studies evaluating the incidence, nature, magnitude and/or duration of bacteremia after periodontal treatment. The pre-surgical antibiotics have been studied particullary over Gram positive bacterial but not over gram negative bacterial and their secondary effects over the systemic pro-inflamation. Objective: to evaluate the efficacy of intensive periodontal therapy and pre-medication with oral amoxicilline on inflammatory bio-markers and the incidence, duration and magnitude of bacteremia in patients with chronic periodontitis.
Read the detailed description
A randomized, triple-blind clinical trial with 90 participants will be conducted (age range18-65 years) with chronic periodontitis will be received and intensive periodontal therapy under local anaesthesia. Participants will be randomly assigned using block randomization in two groups. Test group premedication with 2 gr of oral amoxicilline 1 hour before periodontal treatment and control group with 2 gr of placebo 1 hour before treatment. High-sensitivity assays will be used to quantify serum concentrations of inflammatory marker (Interleukin (IL-1β), Interleukin 6, Tumour necrosis factor α, MCP 1, C Reactive Protein (CRP), plasma haemostatic (D-dimer), and von Willebrand factor antigen (r-WF:Ag).
Samples of blood will be taken at baseline (before treatment), inmediatly finished the treatment, 30 minutes and 1, seven and 30 days after treatment to asses bacteremia and inflammatory markers.
Bacterial isolation and identification: Bacterial colonies will be isolated on both selective and nonselective culture medium for aerobes and anaerobes bacteria. Sensitive Digital quantitative polymerase chain reaction will be used to quantify bacteria.
Concentrations of CPRus, inflammatory, haemostatic and endotellial cell activation markers will be quantified by high-sensitive enzyme liked inmunosorbent assays according to the manufacturer´s protocol. For each cytokine, comparisons between groups will be made by time. The levels of cytokines expressed in picograms will be transformed into international units for the statistical analysis.
In case it follows a normal distribution, an analysis of variance (ANOVA) for repeated measurements between groups with post hoc corrections made by Wilcoxon test will be used. In case it doesn´t follow a normal distribution, Non parametric test such as Friedman´s test will be used. Values of p<0.05 will be accepted as statiscally significant.
- Conditions
- Chronic Periodontitis, Bacteremia
- Being tested
- Amoxicillin, Placebo
- Keywords
- Periodontal disease, Bacteremia, Amoxicilline, Inflamatory markers
- Medical subject headings
- Chronic Periodontitis, Bacteremia, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Also called Intensive Periodontal treatment
Intensive Periodontal treatment; Pre-medication with 2 gr of oral Amoxicillin 1 hour before treatment
PlaceboOther
Also called Intensive Periodontal treatment
Intensive Periodontal treatment; Pre-medication with 2 gr of Placebo 1 hour before treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Intensive Periodontal treatment and pre-medication with 2 gr of oral amoxicilline 1 hour before treatment Receives: Drug: Amoxicillin |
| PLACEBO | Placebo comparator | Intensive Periodontal treatment with 2 gr of Placebo 1 hour before treatment Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence bacteria "Change"
absence or presence bacterial in blood
Measured: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
Change of Nature of the bacteria
bacterial strain
Measured: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
Change of magnitude of bacteremia
Colony forming units (CFU)
Measured: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
Duration of bacteremia
Bacteremia´s minutes
Measured: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
Secondary outcomes (6)
Change of levels of Interleukin
Levels pg/ml
Measured: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
Change of C Reactive Protein (CRP)
Levels mg/L
Measured: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
Change of levels of plasma haemostatic (D-dimer)
Levels ng/ml
Measured: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
Change of von Willebrand factor antigen (r-WF:Ag)
Levels ng/ml
Measured: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
Change of Pressure blood
Millimeter of mercury (mmHg)
Measured: baseline, immediately finished the treatment
Change of Heart rate.
Beats per Minute (BPM)
Measured: baseline, immediately finished the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start21 Sep 2017
- Primary completion30 Apr 2018 (estimated)
- Study completion31 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A triple-blind randomized controlled trial with 90 participants will be conducted. Participants will be assigned using block randomization in two groups and will received intensive periodontal therapy under local anaesthesia. Test group pre-medication with 2 gr of oral amoxicilline 1 hour before treatment. Control group with 2 gr of placebo 1 hour before treatment. Samples of blood will be taken at baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th to asses bacteremia and inflammatory markers
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad El Bosque, Bogotá
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Antonio Noriega Frontado, Universidad El Bosque, Bogotá
- Investigators
- Luis Antonio Noriega Frontado, MSc (c), Principal investigator, El Bosque University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354338
- Sponsor's protocol ID
- UIBObosque
- Acronym
- AMX-Perio
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Academy of Periodontology Task Force Report on the Update to the 1999 Classification of Periodontal Diseases and Conditions. J Periodontol. 2015 Jul;86(7):835-8. doi: 10.1902/jop.2015.157001. Epub 2015 May 27. No abstract available.
PubMed 26125117Arduino PG, Tirone F, Schiorlin E, Esposito M. Single preoperative dose of prophylactic amoxicillin versus a 2-day postoperative course in dental implant surgery: A two-centre randomised controlled trial. Eur J Oral Implantol. 2015 Summer;8(2):143-9.
PubMed 26021225Axelsson P, Nystrom B, Lindhe J. The long-term effect of a plaque control program on tooth mortality, caries and periodontal disease in adults. Results after 30 years of maintenance. J Clin Periodontol. 2004 Sep;31(9):749-57. doi: 10.1111/j.1600-051X.2004.00563.x.
PubMed 15312097Beck J, Garcia R, Heiss G, Vokonas PS, Offenbacher S. Periodontal disease and cardiovascular disease. J Periodontol. 1996 Oct;67(10 Suppl):1123-37. doi: 10.1902/jop.1996.67.10s.1123.
PubMed 8910831Castillo DM, Sanchez-Beltran MC, Castellanos JE, Sanz I, Mayorga-Fayad I, Sanz M, Lafaurie GI. Detection of specific periodontal microorganisms from bacteraemia samples after periodontal therapy using molecular-based diagnostics. J Clin Periodontol. 2011 May;38(5):418-27. doi: 10.1111/j.1600-051X.2011.01717.x. Epub 2011 Mar 11.
PubMed 21392048Cobb CM. Clinical significance of non-surgical periodontal therapy: an evidence-based perspective of scaling and root planing. J Clin Periodontol. 2002 May;29 Suppl 2:6-16.
PubMed 12010523D'Aiuto F, Parkar M, Nibali L, Suvan J, Lessem J, Tonetti MS. Periodontal infections cause changes in traditional and novel cardiovascular risk factors: results from a randomized controlled clinical trial. Am Heart J. 2006 May;151(5):977-84. doi: 10.1016/j.ahj.2005.06.018.
PubMed 16644317D'Aiuto F, Parkar M, Tonetti MS. Acute effects of periodontal therapy on bio-markers of vascular health. J Clin Periodontol. 2007 Feb;34(2):124-9. doi: 10.1111/j.1600-051X.2006.01037.x. Epub 2007 Jan 3.
PubMed 17214734Daly CG, Mitchell DH, Highfield JE, Grossberg DE, Stewart D. Bacteremia due to periodontal probing: a clinical and microbiological investigation. J Periodontol. 2001 Feb;72(2):210-4. doi: 10.1902/jop.2001.72.2.210.
PubMed 11288795Dayer MJ, Jones S, Prendergast B, Baddour LM, Lockhart PB, Thornhill MH. Incidence of infective endocarditis in England, 2000-13: a secular trend, interrupted time-series analysis. Lancet. 2015 Mar 28;385(9974):1219-28. doi: 10.1016/S0140-6736(14)62007-9. Epub 2014 Nov 18.
PubMed 25467569
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intensive Periodontal Therapy and Premedication With Oral Amoxicilline on Inflammatory Markers and Bacteremia in Patients With Chronic Periodontitis. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03354338
- Acronym / sponsor ID
- AMX-Perio / UIBObosque
- Conditions
- Chronic Periodontitis, Bacteremia
- Keywords
- Periodontal disease, Bacteremia, Amoxicilline, Inflamatory markers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universidad El Bosque, BogotáUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 31 Jul 2018 (estimated)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are not published studies evaluating the incidence, nature, magnitude and/or duration of bacteremia after periodontal treatment. The pre-surgical antibiotics have been studied particullary over Gram positive bacterial but not over gram negative bacterial and their secondary effects over the systemic pro-inflamation. Objective: to evaluate the efficacy of intensive periodontal therapy and pre-medication with oral amoxicilline on inflammatory bio-markers and the incidence, duration and magnitude of bacteremia in patients with chronic periodontitis.
Detailed description
A randomized, triple-blind clinical trial with 90 participants will be conducted (age range18-65 years) with chronic periodontitis will be received and intensive periodontal therapy under local anaesthesia. Participants will be randomly assigned using block randomization in two groups. Test group premedication with 2 gr of oral amoxicilline 1 hour before periodontal treatment and control group with 2 gr of placebo 1 hour before treatment. High-sensitivity assays will be used to quantify serum concentrations of inflammatory marker (Interleukin (IL-1β), Interleukin 6, Tumour necrosis factor α, MCP 1, C Reactive Protein (CRP), plasma haemostatic (D-dimer), and von Willebrand factor antigen (r-WF:Ag).
Samples of blood will be taken at baseline (before treatment), inmediatly finished the treatment, 30 minutes and 1, seven and 30 days after treatment to asses bacteremia and inflammatory markers.
Bacterial isolation and identification: Bacterial colonies will be isolated on both selective and nonselective culture medium for aerobes and anaerobes bacteria. Sensitive Digital quantitative polymerase chain reaction will be used to quantify bacteria.
Concentrations of CPRus, inflammatory, haemostatic and endotellial cell activation markers will be quantified by high-sensitive enzyme liked inmunosorbent assays according to the manufacturer´s protocol. For each cytokine, comparisons between groups will be made by time. The levels of cytokines expressed in picograms will be transformed into international units for the statistical analysis.
In case it follows a normal distribution, an analysis of variance (ANOVA) for repeated measurements between groups with post hoc corrections made by Wilcoxon test will be used. In case it doesn´t follow a normal distribution, Non parametric test such as Friedman´s test will be used. Values of p<0.05 will be accepted as statiscally significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A triple-blind randomized controlled trial with 90 participants will be conducted. Participants will be assigned using block randomization in two groups and will received intensive periodontal therapy under local anaesthesia. Test group pre-medication with 2 gr of oral amoxicilline 1 hour before treatment. Control group with 2 gr of placebo 1 hour before treatment. Samples of blood will be taken at baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th to asses bacteremia and inflammatory markers
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: AmoxicillinIntensive Periodontal treatment and pre-medication with 2 gr of oral amoxicilline 1 hour before treatment |
| PLACEBO | Placebo comparator | Other: PlaceboIntensive Periodontal treatment with 2 gr of Placebo 1 hour before treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with chronic periodontitis (Ameriacam Academy of Periodontology 2015), having at least 2 teeth for quadrant with periodontal probing pockets depth ≥ 5 mm.
Key exclusion criteria (1 listed)
- Pregnant and lactating women, Diabetes, hypertension, Obesity, Allergy to penicillin, consumption of systemic antimicrobial or anti-inflamatory drugs in the last 2 months, Autoimmune diseases, patients with medical conditions that required antibiotic premedication such as prosthetic heart valve replacement, skeletal joint replacement, previous history of infective endocarditis and history of rheumatic fever.
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 |
|---|---|---|
| AmoxicillinAlso: Intensive Periodontal treatmentIntensive Periodontal treatment; Pre-medication with 2 gr of oral Amoxicillin 1 hour before treatment | Drug | Experimental Group |
| PlaceboAlso: Intensive Periodontal treatmentIntensive Periodontal treatment; Pre-medication with 2 gr of Placebo 1 hour before treatment | Other | PLACEBO |
Primary outcome
Incidence bacteria "Change"
Time frame: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
absence or presence bacterial in blood
Change of Nature of the bacteria
Time frame: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
bacterial strain
Change of magnitude of bacteremia
Time frame: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
Colony forming units (CFU)
Duration of bacteremia
Time frame: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th
Bacteremia´s minutes
6 secondary outcomes
Change of levels of Interleukin
Time frame: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
Change of C Reactive Protein (CRP)
Time frame: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
Change of levels of plasma haemostatic (D-dimer)
Time frame: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
Change of von Willebrand factor antigen (r-WF:Ag)
Time frame: baseline, immediately finished the treatment, 30 minutes, 24 hours, 7 days and day 30th later
Change of Pressure blood
Time frame: baseline, immediately finished the treatment
Change of Heart rate.
Time frame: baseline, immediately finished the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Background: PubMed 26125117American Academy of Periodontology Task Force Report on the Update to the 1999 Classification of Periodontal Diseases and Conditions. J Periodontol. 2015 Jul;86(7):835-8. doi: 10.1902/jop.2015.157001. Epub 2015 May 27. No abstract available.
- Background: PubMed 26021225Arduino PG, Tirone F, Schiorlin E, Esposito M. Single preoperative dose of prophylactic amoxicillin versus a 2-day postoperative course in dental implant surgery: A two-centre randomised controlled trial. Eur J Oral Implantol. 2015 Summer;8(2):143-9.
- Background: PubMed 15312097Axelsson P, Nystrom B, Lindhe J. The long-term effect of a plaque control program on tooth mortality, caries and periodontal disease in adults. Results after 30 years of maintenance. J Clin Periodontol. 2004 Sep;31(9):749-57. doi: 10.1111/j.1600-051X.2004.00563.x.
- Background: PubMed 8910831Beck J, Garcia R, Heiss G, Vokonas PS, Offenbacher S. Periodontal disease and cardiovascular disease. J Periodontol. 1996 Oct;67(10 Suppl):1123-37. doi: 10.1902/jop.1996.67.10s.1123.
- Background: PubMed 21392048Castillo DM, Sanchez-Beltran MC, Castellanos JE, Sanz I, Mayorga-Fayad I, Sanz M, Lafaurie GI. Detection of specific periodontal microorganisms from bacteraemia samples after periodontal therapy using molecular-based diagnostics. J Clin Periodontol. 2011 May;38(5):418-27. doi: 10.1111/j.1600-051X.2011.01717.x. Epub 2011 Mar 11.
- Background: PubMed 12010523Cobb CM. Clinical significance of non-surgical periodontal therapy: an evidence-based perspective of scaling and root planing. J Clin Periodontol. 2002 May;29 Suppl 2:6-16.
- Background: PubMed 16644317D'Aiuto F, Parkar M, Nibali L, Suvan J, Lessem J, Tonetti MS. Periodontal infections cause changes in traditional and novel cardiovascular risk factors: results from a randomized controlled clinical trial. Am Heart J. 2006 May;151(5):977-84. doi: 10.1016/j.ahj.2005.06.018.
- Background: PubMed 17214734D'Aiuto F, Parkar M, Tonetti MS. Acute effects of periodontal therapy on bio-markers of vascular health. J Clin Periodontol. 2007 Feb;34(2):124-9. doi: 10.1111/j.1600-051X.2006.01037.x. Epub 2007 Jan 3.
- Background: PubMed 11288795Daly CG, Mitchell DH, Highfield JE, Grossberg DE, Stewart D. Bacteremia due to periodontal probing: a clinical and microbiological investigation. J Periodontol. 2001 Feb;72(2):210-4. doi: 10.1902/jop.2001.72.2.210.
- Background: PubMed 25467569Dayer MJ, Jones S, Prendergast B, Baddour LM, Lockhart PB, Thornhill MH. Incidence of infective endocarditis in England, 2000-13: a secular trend, interrupted time-series analysis. Lancet. 2015 Mar 28;385(9974):1219-28. doi: 10.1016/S0140-6736(14)62007-9. Epub 2014 Nov 18.
- 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.
Luis Antonio Noriega Frontado, MSc (c) principal investigator
El Bosque University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amoxicillin in people with Chronic Periodontitis and Bacteremia, run by Universidad El Bosque, Bogotá at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 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 Colombia. 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 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?
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?
Incidence bacteria "Change" (time frame: baseline (before treatment), immediately finished the treatment, 30 minutes later, after 24 hours, after seven days and on the day 30th). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03354338, which also lists 10 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 27 Nov 2017.