Long-term Safety of TIPPhase 4NCT01775137
Ext. Long-term Safety Study in CF Patients: Single Arm TIP
A Phase 4 study testing TBM100 in people with Long-term Safety of TIP, run by Novartis Pharmaceuticals at 21 sites in 9 countries.
Trial summary
The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Long-term Safety of TIP
- What is being tested?
- TBM100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 21 sitesin 9 countries
- Study dates
- Feb 2013to Nov 2014
- Phase
- Phase 4
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completion of the core study CTBM100C2401 and able to comply with all protocol requirements of the extension study
Who cannot join
- Serum creatinine 2mg/dl, BUN 40mg/dl or proteinuria 2+ or more at the time of entry into the extension
- Use of loop diuretics within 7 days prior to entry into the extension study
- Pregnant or nursing women
- Women of child bearing potential unless using highly effective method of contraception as indicated in the protoco
Trial locations and contacts
21 sites in 9 countries.
21 sites in 9 countries
Italy5 sites
Novartis Investigative Site
Florence, FI, 50139
Novartis Investigative Site
Messina, ME, 98125
Novartis Investigative Site
Palermo, Italy, 90100
Novartis Investigative Site
Roma, 00161
Novartis Investigative Site
Verona, VR, 37126
United States4 sites
Novartis Investigative Site
Akron, Ohio, 44308
Novartis Investigative Site
Charleston, South Carolina, 29425
Novartis Investigative Site
Dallas, Texas, 75230
Novartis Investigative Site
Houston, Texas, 77030
Argentina3 sites
Novartis Investigative Site
Caba, Buenos Aires, C1425DTG
Novartis Investigative Site
Capital Federal, Buenos Aires, C1425EFD
Novartis Investigative Site
Córdoba, Córdoba Province, X5014AKN
Australia2 sites
Novartis Investigative Site
New Lambton Heights, New South Wales, 2305
Novartis Investigative Site
Parkville, Victoria, 3052
Mexico2 sites
Novartis Investigative Site
Mexico City, Mexico City, 06720
Novartis Investigative Site
Monterrey, Nuevo León, 64020
Spain2 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Valencia, Valencia, 46026
About this study
Official title: A 48 Week Extension to CTBM100C2401, a Single Arm, Open-label, Multicenter, Phase IV Extension Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis Who Completed Participation in CTBM100C2401.
The purpose of this extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.
- Conditions
- Long-term Safety of TIP
- Being tested
- TBM100
- Keywords
- CF, Open-label, TIP, phase IV, extension study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBM100Drug
Tobramycin inhalation powder (TIP) 112mg/b.i.d
| Study group | Role | What they receive |
|---|---|---|
| TBM100 | Experimental | TIP 112 mg/b.i.d Receives: Drug: TBM100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 12 Treatment Cycles
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Based on the severity, AEs were categorised into 3 types as mild, moderate and severe. Death was a fatal event leading to permanent cessations of all vital functions of the body.
Measured: Baseline (start of study treatment in core study) to Day 673 (end of the extension study)
Secondary outcomes (19)
Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles
FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. FEV1% predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day*FEV1% predicted - baseline FEV1% predicted) / baseline FEV1 % predicted) x 100.
Measured: Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
Absolute Change From Baseline in Pseudomonas Aeruginosa Sputum Density Over 12 Treatment Cycles
Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. Absolute change was determined using the formula = (Post-baseline value- baseline value). If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes.
Measured: Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day
Tobramycin Minimum Inhibitory Concentration (MIC) 50 and MIC 90 Values for Pseudomonas Aeruginosa Over 12 Treatment Cycles
MIC was defined as the lowest concentration of an antimicrobial agent required to inhibit the visible growth of a microorganism after overnight incubation. Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested (mucoid,dry and small colony variant biotypes).
Measured: Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
Percentage of Participants Who Used New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles
The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study.
Measured: Baseline of core study, Day 673 (end of the extension study)
Total Number of Days of New Anti-pseudomonal Antibiotics Use Over 12 Treatment Cycles
The total number of days with usage of new anti-pseudomonal antibiotic were determined.
Measured: Baseline of core study, Day 673 (end of the extension study)
Time to Use of New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles
Time to first usage of anti-pseudomonal antibiotic was determined using Kaplan Meier estimate. Participants without an event were censored at the date of the last available post-baseline measurement.
Measured: Baseline of core study, Day 673 (end of the extension study)
The Percentage of the Participants Hospitalized Due to Serious Respiratory-related AEs Were Determined During the Study.
The percentage of the participants hospitalized due to serious respiratory-related AEs were determined during the study.
Measured: Baseline of core study, Day 673 (end of the extension study)
Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles
The total number of hospitalization days due to serious respiratory-related adverse events was analyzed using Kaplan-Meier estimate.
Measured: Baseline of core study, Day 673 (end of the extension study)
Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles
The day of first hospitalization due to serious respiratory-related adverse events was analysed using Kaplan Meier estimate.
Measured: Baseline of core study, Day 673 (end of the extension study)
Acute Relative Change From Pre-dose to 30-minute Post-dose in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles
FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. Relative change in FEV1 % predicted was calculated by using the formula = 100 *(30-min post-dose value - pre-dose value) / pre-dose value.
Measured: Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 6 Treatment Cycles in Extension Study
FEV1 was defined as the volume of air expired in 1 second. FEV1 was assessed as a pulmonary function by using spirometry tests in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria. FEV1% predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day*FEV1% predicted - baseline FEV1% predicted) / baseline FEV1 % predicted) x 100.
Measured: Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
Absolute Change From Baseline in Pseudomonas Aeruginosa Density Over 6 Treatment Cycles in Extension Study
Microbiological data was collected to understand the direct impact of the drug on the pathogens. Sputum samples were cultured for the presence of three Pseudomonas aeruginosa (P. aeruginosa) biotypes measured were mucoid, dry and small colony variant. If no P. aeruginosa was isolated for a visit, log10 colony forming units (CFU) was imputed with log10 (19) for all biotypes. Absolute change was calculated by using the formula = (Value at actual time point - start of extension value).
Measured: Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
Percentage of Participants Who Used New Anti-pseudomonal Antibiotics in Extension Study
The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study.
Measured: Baseline of extension study, Day 673 (end of extension study)
Total Number of Days of New Anti-pseudomonal Antibiotics Use in Extension Study
The total number of days with usage of new anti-pseudomonal antibiotic were determined.
Measured: Baseline of extension study, Day 673 (end of extension study)
Time to Use of New Anti-pseudomonal Antibiotics in Extension Study
Time to first usage of anti-pseudomonal antibiotic was determined using Kaplan Meier estimate. Participants without an event were censored at the date of the last available post-baseline measurement.
Measured: Baseline of extension study, Day 673 (end of extension study)
Percentage of Participants Hospitalized Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
The percentage of the participants hospitalized due to serious respiratory-related AEs were determined during the extension study.
Measured: Baseline of extension study, Day 673 (end of the extension study)
Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
The total number of hospitalisation days due to serious respiratory-related adverse events was analysed using Kaplan-Meier estimate.
Measured: Baseline of extension study, Day 673 (end of extension study)
Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
The day of first hospitalization due to serious respiratory related adverse events was analysed using Kaplan Meier estimate.
Measured: Baseline of extension study, Day 673 (end of extension study)
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 6 Treatment Cycles in Extension Study
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalisation, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Death was a fatal event leading to permanent cessations of all vital functions of the body.
Measured: Baseline (start of study treatment in extension study) to Day 673 (end of the extension study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2014
- Study completionNov 2014
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 Long-term Safety of TIPStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775137
- Sponsor's protocol ID
- CTBM100C2401E1
- Status last verified
- Nov 2015
- First submitted
- 22 Jan 2013
- Last updated
- 6 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 48 Week Extension to CTBM100C2401, a Single Arm, Open-label, Multicenter, Phase IV Extension Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis Who Completed Participation in CTBM100C2401.
- ClinicalTrials.gov ID
- NCT01775137
- Acronym / sponsor ID
- CTBM100C2401E1
- Conditions
- Long-term Safety of TIP
- Keywords
- CF, Open-label, TIP, phase IV, extension study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Posted 6 Nov 2015
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 extension study is to collect additional 48 weeks of safety data from patients taking TIP who have completed the core study CTBM100C2401. The purpose of collecting second year safety data through this study is to obtain long-term (2 years) safety data of TIP.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBM100 | Experimental | Drug: TBM100TIP 112 mg/b.i.d |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Completion of the core study CTBM100C2401 and able to comply with all protocol requirements of the extension study
Key exclusion criteria (4 listed)
- Serum creatinine 2mg/dl, BUN 40mg/dl or proteinuria 2+ or more at the time of entry into the extension
- Use of loop diuretics within 7 days prior to entry into the extension study
- Pregnant or nursing women
- Women of child bearing potential unless using highly effective method of contraception as indicated in the protoco
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 |
|---|---|---|
| TBM100Tobramycin inhalation powder (TIP) 112mg/b.i.d | Drug | TBM100 |
Primary outcome
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 12 Treatment Cycles
Time frame: Baseline (start of study treatment in core study) to Day 673 (end of the extension study)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes. Based on the severity, AEs were categorised into 3 types as mild, moderate and severe. Death was a fatal event leading to permanent cessations of all vital functions of the body.
19 secondary outcomes
Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles
Time frame: Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
Absolute Change From Baseline in Pseudomonas Aeruginosa Sputum Density Over 12 Treatment Cycles
Time frame: Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day
Tobramycin Minimum Inhibitory Concentration (MIC) 50 and MIC 90 Values for Pseudomonas Aeruginosa Over 12 Treatment Cycles
Time frame: Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
Percentage of Participants Who Used New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles
Time frame: Baseline of core study, Day 673 (end of the extension study)
Total Number of Days of New Anti-pseudomonal Antibiotics Use Over 12 Treatment Cycles
Time frame: Baseline of core study, Day 673 (end of the extension study)
Time to Use of New Anti-pseudomonal Antibiotics Over 12 Treatment Cycles
Time frame: Baseline of core study, Day 673 (end of the extension study)
The Percentage of the Participants Hospitalized Due to Serious Respiratory-related AEs Were Determined During the Study.
Time frame: Baseline of core study, Day 673 (end of the extension study)
Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles
Time frame: Baseline of core study, Day 673 (end of the extension study)
Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) Over 12 Treatment Cycles
Time frame: Baseline of core study, Day 673 (end of the extension study)
Acute Relative Change From Pre-dose to 30-minute Post-dose in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 12 Treatment Cycles
Time frame: Baseline (start of study treatment in core study), Day 29, Day 85, Day 141, Day 197, Day 253, Day 309, Day 337, Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted Over 6 Treatment Cycles in Extension Study
Time frame: Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
Absolute Change From Baseline in Pseudomonas Aeruginosa Density Over 6 Treatment Cycles in Extension Study
Time frame: Baseline (start of study treatment in extension study), Day 365, Day 421, Day 477, Day 533, Day 589, Day 645, 673 (end of the extension study)
Percentage of Participants Who Used New Anti-pseudomonal Antibiotics in Extension Study
Time frame: Baseline of extension study, Day 673 (end of extension study)
Total Number of Days of New Anti-pseudomonal Antibiotics Use in Extension Study
Time frame: Baseline of extension study, Day 673 (end of extension study)
Time to Use of New Anti-pseudomonal Antibiotics in Extension Study
Time frame: Baseline of extension study, Day 673 (end of extension study)
Percentage of Participants Hospitalized Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
Time frame: Baseline of extension study, Day 673 (end of the extension study)
Number of Hospitalization Days Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
Time frame: Baseline of extension study, Day 673 (end of extension study)
Time to First Hospitalization Due to Respiratory Related Serious Adverse Events (SAEs) in Extension Study
Time frame: Baseline of extension study, Day 673 (end of extension study)
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 6 Treatment Cycles in Extension Study
Time frame: Baseline (start of study treatment in extension study) to Day 673 (end of the extension study)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
21 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TBM100 in people with Long-term Safety of TIP, run by Novartis Pharmaceuticals at 21 sites in 9 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 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: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy, United States, Argentina, Australia, Mexico and 4 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?
Yes. Results are posted in the registry (first posted 6 Nov 2015). 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 Adverse Events (AEs), Serious Adverse Events (SAEs), AEs/SAEs Leading to Discontinuation of Study Drug and Deaths Over 12 Treatment Cycles (time frame: Baseline (start of study treatment in core study) to Day 673 (end of the extension study)). 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 6 Nov 2015.