Clostridium DifficilePhase 4EXTENDNCT02254967
A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population
A Phase 4 study testing Fidaxomicin and Vancomycin in people with Clostridium Difficile, run by Astellas Pharma Europe Ltd. at 109 sites in 22 countries.
Trial summary
The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Fidaxomicin and Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 109 sitesin 22 countries
- Study dates
- 6 Nov 2014to 5 May 2016
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CDI is confirmed by clinical symptoms (either > 3 unformed bowel movements or ≥ 200ml of unformed stool (for subjects having rectal collection devices)) in the 24 hours prior to randomization and CDI test confirmed positive for presence of C. difficile toxin A or B in stool within 48 hr prior to randomization.
- Subject agrees not to participate in another interventional study whilst participating in this study.
Who cannot join
- Subject is taking or requiring to be treated with prohibited medications
- Subject has received more than one day of dosing of any therapy for CDI within the last 48 hours
- Subject has experienced more than 2 previous episodes of CDI in the 3 months prior to study enrolment
- Subject is unable to swallow oral study medication.
- Subject has a current diagnosis of toxic megacolon.
- Subject is not willing to adhere to the provisions of treatment and observation specified in the protocol.
Show all 9Show fewer
- Subject has been randomized into this study previously, has taken any investigational drug within 28 days or 5 half lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor.
- Subject has previously participated in a CDI vaccine study
- Subject has hypersensitivity to fidaxomicin, vancomycin or any of its components.
Trial locations and contacts
109 sites in 22 countries.
109 sites in 22 countries
France9 sites
Site FR33003
Bordeaux, 33000
Site FR33008
Clermont-Ferrand, 63003
Site FR33006
Lille, 59037
Site FR33005
Nantes, 44000
Site FR33004
Nîmes, 30000
Site FR33001
Paris, 75010
Site FR33007
Paris, 75012
Site FR33002
Rennes, 35037
Site FR33009
Saint-Priest-en-Jarez, 42270
Greece9 sites
Site GR30005
Athens, 10675
Site GR30008
Athens, 115 25
Site GR30001
Athens, 11527
Site GR30004
Athens, 11527
Site GR30009
Athens, 12461
Site GR30007
Athens, 14561
Site GR30002
Herakleion, Crete, 70013
Site GR30006
Larissa, 41221
Site GR30010
Thessaloniki, 546 36
Italy9 sites
Site IT39009
Florence, 50134
Site IT39005
Genova, 16132
Site IT39004
Milan, 20122
Site IT39003
Monza, 20900
Site IT39007
Naples, 80131
Site IT39002
Padova, 35128
Site IT39001
Pisa, 56124
Site IT39006
Roma, 00168
Site IT39010
Torino, 10154
Hungary8 sites
Site HU36004
Békéscsaba, H-5600
Site HU36010
Budapest, 1082
Site HU36009
Budapest, 1088
Site HU36001
Debrecen, H-4043
Site HU36006
Gyula, H-5700
Site HU36005
Mosonmagyaróvár, H-9200
Site HU36008
Orosháza, H-5900
Site HU36007
Pécs, H-7624
Turkey (Türkiye)7 sites
Site TR90003
Adana, 01330
Site TR90002
Ankara, 06100
Site TR90007
Ankara, 06100
Site TR90001
Antalya, 07059
Site TR90006
Eskişehir, 26480
Site TR90005
Istanbul, 34662
Site TR90004
Istanbul, 34890
Germany6 sites
Site DE49001
Cologne, 50937
Site DE49011
Cologne, 51067
Site DE49012
Hamburg, 25599
Site DE49006
Leipzig, 04103
Site DE49016
Lübeck, 23538
Site DE49008
Marburg, 35043
Poland6 sites
Site PL48004
Gdynia, 81-348
Site PL48012
Lodz, PL, 91-347
Site PL48011
Szczecin, 71-899
Site PL48008
Warsaw, 02-507
Site PL48002
Warsaw, 02-781
Site PL48003
Zgierz, 95-100
United Kingdom6 sites
Site GB44008
Blackpool, FY3 8NR
Site GB44006
Bristol, UK, BS2 8HW
Site GB44005
Cardiff, CF14 4XW
Site GB44010
London, E1 1BB
Site GB44003
Sutton in Ashfield, Nottinghamshire, NG17 4JL
Site GB44009
Truro, TR1 3LJ
Belgium5 sites
Site BE32007
Aalst, 9300
Site BE32006
Bruges, B-8000
Site BE32001
Brussels, 1000
Site BE32005
Brussels, B-1020
Site BE32008
Liège, 4000
Czechia5 sites
Site CZ42002
Brno-Bohunice, 62500
Site CZ42005
Kyjov, 69733
Site CZ42004
Opava, 74601
Site CZ42003
Prague, 15006
Site CZ42001
Praha 8 - Libeň, 18081
Portugal5 sites
Site PT35101
Almada, 2800-525
Site PT35102
Amadora, 2720-276
Site PT35106
Cotter, 4835-044
Site PT35104
Vila Nova de Gaia, 4434-502
Site PT35107
Vila Real, 5000-508
Croatia4 sites
Site HR38506
Osijek, 31000
Site HR38503
Rijeka, 51000
Site HR38505
Zadar, 23 000
Site HR38501
Zagreb, 10000
Slovenia4 sites
Site SI38601
Ljubljana, 1000
Site SI38605
Ljubljana, 1000
Site SI38602
Maribor, 2000
Site SI38603
Murska Sobota, 9000
Spain4 sites
Site ES34003
Barakaldo, Vizcaya, 48903
Site ES34004
Barcelona, 08035
Site ES34005
Madrid, 28040
Site ES34006
Valencia, 46026
Sweden4 sites
Site SE46002
Gothenburg, 41685
Site SE46004
Jönköping, 55185
Site SE46001
Lund, 22185
Site SE46005
Uppsala, 75185
Austria3 sites
Site AT43002
Graz, 8020
Site AT43003
Linz, 4010
Site AT43001
Salzburg, 5020
Denmark3 sites
Site DK45001
Herlev, 2730
Site DK45005
Hillerød, 3400
Site DK45004
Nykøbing Falster, 4800
Romania3 sites
Site RO40001
Bucharest, 21105
Site RO40003
Cluj-Napoca, 400348
Site RO40002
Lasi, 700116
Switzerland3 sites
Site CH41001
Lugano, Canton Ticino, CH-6903
Site CH41002
Sankt Gallen, 9007
Site CH41004
Zurich, 8006
About this study
Official title: A Phase IIIB/IV Randomized, Controlled, Open-label, Parallel Group Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration Fidaxomicin Therapy in the Sustained Clinical Cure of Clostridium Difficile Infection in an Older Population
The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).
- Conditions
- Clostridium Difficile
- Being tested
- Fidaxomicin, Vancomycin
- Keywords
- Aged, Fidaxomicin, Clostridium Difficile, Vancomycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FidaxomicinDrug
Also called OPT-80, ASP2819, Dificlir, Dificid
oral tablets administered in an extended pulsed regimen
VancomycinDrug
Also called Vancocin
oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Fidaxomicin Extended Pulsed Regimen (EPFX) | Experimental | Participants receive 200 mg fidaxomicin from day 1 to day 5 twice daily, followed by a 1-day gap (day 6) before starting alternate day dosing of 1 tablet of fidaxomicin 200 mg once daily from day 7 to day 25. Receives: Drug: Fidaxomicin |
| Vancomycin | Experimental | Participants receive 125 mg vancomycin from day 1 to day 10, 4 times daily. Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with a Sustained Clinical Cure of CDI at 30 Days after End of Treatment
Sustained clinical cure is defined as an assessment of clinical response at test of cure (TOC; day 12 for vancomycin and day 27 or 12 for EPFX arm) and no recurrence of CDI from TOC until time of assessment. Clinical response is determined by the investigator based on the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) criteria at TOC. Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity (clinical, laboratory, radiological) improves and no new signs of severe disease develops.
Measured: Day 40 (for vancomycin) and day 55 (for fidaxomicin extended pulsed regimen [EPFX])
Secondary outcomes (8)
Percentage of Participants with a Sustained Clinical Cure of CDI at Day 40, Day 55 and Day 90
Sustained clinical cure is defined as an assessment of clinical response at test of cure (TOC; day 12 for vancomycin and day 27 or 12 for EPFX arm) and no recurrence of CDI from TOC until time of assessment. Clinical response is determined by the investigator based on the ESCMID criteria at TOC. Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity (clinical, laboratory, radiological) improves and no new signs of severe disease develops.
Measured: Day 40, 55, 90
Percentage of Participants with a Clinical Response of CDI at 2 Days after End of Treatment
Clinical response is determined by the investigator based on the ESCMID criteria (i.e., Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity [clinical, laboratory, radiological] improves and no new signs of severe disease develops. Treatment response should be daily observed and evaluated after at least three days, assuming that the patient is not worsening on treatment) at TOC.
Measured: Day 12, 27
Percentage of Participants with a Clinical Response of CDI at Day 12
Clinical response is determined by the investigator based on the ESCMID criteria (i.e., Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity [clinical, laboratory, radiological] improves and no new signs of severe disease develops. Treatment response should be daily observed and evaluated after at least three days, assuming that the participant is not worsening on treatment) at TOC.
Measured: Day 12
Number of Participants with a Relapse on Day 90 as Determined by Whole Genome Sequencing of C. Difficile Isolates
For participants with a recurrence after TOC, whole genome sequencing of isolates is performed on paired samples from day 1 and the day of the confirmed recurrence. Relapse is defined as paired isolates from a single recurrent participant with ≤ 2 single nucleotide variations (SNVs).
Measured: Baseline through day 90
Time to Resolution of Diarrhea (TTROD)
Time to resolution of diarrhea is defined as the time elapsing (in hours rounded up from minutes > 30) from the start of treatment (time of first dose of study drug) to resolution of diarrhea (time of the last unformed bowel movement [UBM] the day prior to the first of 2 consecutive days of ≤ 3 UBMs, > 50% reduction in number of stools or > 75% reduction in volume of liquid stool) that are sustained through to TOC.
Measured: Up to day 10 (for vancomycin) or up to day 25 (for EPFX)
Percentage of Participants with a Recurrence of CDI at Day 40, Day 55 and Day 90
For participants with clinical response at TOC, recurrence of CDI is defined as re-establishment of diarrhea after TOC to an extent (judged by the frequency of passed UBMs) that is greater than the frequency recorded on day 10 for vancomycin arm or day 25 for EPFX arm (2 days prior to TOC), confirmed by a CDI test positive for Toxin A/B and requiring further CDI therapy.
Measured: Day 40, 55, 90
Time to Recurrence of CDI after End of Active Treatment
Time to recurrence of CDI is defined as the time in days from clinical response until onset of recurrence of CDI for participants who respond at TOC.
Measured: From day 10 up to day 90
Disease-free Survival After Day 10
Disease-free survival is defined as the time in days a participant does not have symptoms of diarrhea from day 10 up to day 90 for participants who respond at TOC.
Measured: From day 10 up to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study start6 Nov 2014
- Primary completion27 Mar 2016
- Study completion5 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254967
- Sponsor's protocol ID
- 2819-MA-1002
- Other IDs
- 2013-004619-31
- Acronym
- EXTEND
- Status last verified
- Oct 2024
- First submitted
- 25 Sep 2014
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Cornely OA, Vehreschild MJGT, Adomakoh N, Georgopali A, Karas A, Kazeem G, Guery B. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection: EXTEND study subgroup analyses. Eur J Clin Microbiol Infect Dis. 2019 Jun;38(6):1187-1194. doi: 10.1007/s10096-019-03525-y. Epub 2019 Mar 25.
PubMed 30911926Guery B, Menichetti F, Anttila VJ, Adomakoh N, Aguado JM, Bisnauthsing K, Georgopali A, Goldenberg SD, Karas A, Kazeem G, Longshaw C, Palacios-Fabrega JA, Cornely OA, Vehreschild MJGT; EXTEND Clinical Study Group. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND): a randomised, controlled, open-label, phase 3b/4 trial. Lancet Infect Dis. 2018 Mar;18(3):296-307. doi: 10.1016/S1473-3099(17)30751-X. Epub 2017 Dec 19.
PubMed 29273269
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB/IV Randomized, Controlled, Open-label, Parallel Group Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration Fidaxomicin Therapy in the Sustained Clinical Cure of Clostridium Difficile Infection in an Older Population
- ClinicalTrials.gov ID
- NCT02254967
- Acronym / sponsor ID
- EXTEND / 2819-MA-1002
- Conditions
- Clostridium Difficile
- Keywords
- Aged, Fidaxomicin, Clostridium Difficile, Vancomycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 6 Nov 2014 (actual)
- Primary completion
- 27 Mar 2016 (actual)
- Study completion
- 5 May 2016 (actual)
- First posted
- 2 Oct 2014 (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 main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fidaxomicin Extended Pulsed Regimen (EPFX) | Experimental | Drug: FidaxomicinParticipants receive 200 mg fidaxomicin from day 1 to day 5 twice daily, followed by a 1-day gap (day 6) before starting alternate day dosing of 1 tablet of fidaxomicin 200 mg once daily from day 7 to day 25. |
| Vancomycin | Experimental | Drug: VancomycinParticipants receive 125 mg vancomycin from day 1 to day 10, 4 times daily. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CDI is confirmed by clinical symptoms (either > 3 unformed bowel movements or ≥ 200ml of unformed stool (for subjects having rectal collection devices)) in the 24 hours prior to randomization and CDI test confirmed positive for presence of C. difficile toxin A or B in stool within 48 hr prior to randomization.
- Subject agrees not to participate in another interventional study whilst participating in this study.
Key exclusion criteria (9 listed)
- Subject is taking or requiring to be treated with prohibited medications
- Subject has received more than one day of dosing of any therapy for CDI within the last 48 hours
- Subject has experienced more than 2 previous episodes of CDI in the 3 months prior to study enrolment
- Subject is unable to swallow oral study medication.
- Subject has a current diagnosis of toxic megacolon.
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 |
|---|---|---|
| FidaxomicinAlso: OPT-80, ASP2819, Dificlir, Dificidoral tablets administered in an extended pulsed regimen | Drug | Fidaxomicin Extended Pulsed Regimen (EPFX) |
| VancomycinAlso: Vancocinoral capsule | Drug | Vancomycin |
Primary outcome
Percentage of Participants with a Sustained Clinical Cure of CDI at 30 Days after End of Treatment
Time frame: Day 40 (for vancomycin) and day 55 (for fidaxomicin extended pulsed regimen [EPFX])
Sustained clinical cure is defined as an assessment of clinical response at test of cure (TOC; day 12 for vancomycin and day 27 or 12 for EPFX arm) and no recurrence of CDI from TOC until time of assessment. Clinical response is determined by the investigator based on the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) criteria at TOC. Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity (clinical, laboratory, radiological) improves and no new signs of severe disease develops.
8 secondary outcomes
Percentage of Participants with a Sustained Clinical Cure of CDI at Day 40, Day 55 and Day 90
Time frame: Day 40, 55, 90
Percentage of Participants with a Clinical Response of CDI at 2 Days after End of Treatment
Time frame: Day 12, 27
Percentage of Participants with a Clinical Response of CDI at Day 12
Time frame: Day 12
Number of Participants with a Relapse on Day 90 as Determined by Whole Genome Sequencing of C. Difficile Isolates
Time frame: Baseline through day 90
Time to Resolution of Diarrhea (TTROD)
Time frame: Up to day 10 (for vancomycin) or up to day 25 (for EPFX)
Percentage of Participants with a Recurrence of CDI at Day 40, Day 55 and Day 90
Time frame: Day 40, 55, 90
Time to Recurrence of CDI after End of Active Treatment
Time frame: From day 10 up to day 90
Disease-free Survival After Day 10
Time frame: From day 10 up to day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Derived from this study: PubMed 30911926Cornely OA, Vehreschild MJGT, Adomakoh N, Georgopali A, Karas A, Kazeem G, Guery B. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection: EXTEND study subgroup analyses. Eur J Clin Microbiol Infect Dis. 2019 Jun;38(6):1187-1194. doi: 10.1007/s10096-019-03525-y. Epub 2019 Mar 25.
- Derived from this study: PubMed 29273269Guery B, Menichetti F, Anttila VJ, Adomakoh N, Aguado JM, Bisnauthsing K, Georgopali A, Goldenberg SD, Karas A, Kazeem G, Longshaw C, Palacios-Fabrega JA, Cornely OA, Vehreschild MJGT; EXTEND Clinical Study Group. Extended-pulsed fidaxomicin versus vancomycin for Clostridium difficile infection in patients 60 years and older (EXTEND): a randomised, controlled, open-label, phase 3b/4 trial. Lancet Infect Dis. 2018 Mar;18(3):296-307. doi: 10.1016/S1473-3099(17)30751-X. Epub 2017 Dec 19.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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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.
Medical Director study director
Astellas Pharma Europe Ltd.
109 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fidaxomicin and Vancomycin in people with Clostridium Difficile, run by Astellas Pharma Europe Ltd. at 109 sites in 22 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 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 sites in France, Greece, Italy, Hungary, Turkey (Türkiye) and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants with a Sustained Clinical Cure of CDI at 30 Days after End of Treatment (time frame: Day 40 (for vancomycin) and day 55 (for fidaxomicin extended pulsed regimen [EPFX])). 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 NCT02254967, which also lists 2 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 31 Oct 2024.