Growth Hormone TherapyPhase 2AGANCT00174460
Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
A Phase 2 study testing Somatropin in people with Growth Hormone Therapy and Infant, Very Low Birth Weight, run by Pfizer at 8 sites in Germany.
Trial summary
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Growth Hormone Therapy, Infant, Very Low Birth Weight
- What is being tested?
- Somatropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 8 sitesGermany
- Study dates
- Aug 2005to Mar 2010
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- Prepubertal caucasian boys between 4 and 10 years of age and girls between 4 and 9 years of age.
- Girls: Tanner stage 1 breast development
- Boys: Testis volume <= 3ml
- Tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on growth velocity, insulin sensitivity and body composition).
- (In case of any signs or symptoms of gonadal puberty a GnRH-Test must decide if the subject is still pubertal.)
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- Height <=-2 SD for chronological age (Brandt/Reinken).
- Growth velocity SDS below 0 SD for chronological age (Brandt/Reinken based on 12+/- 3 months observation period before screening).
- Premature born defined as <=1500 g birth weight.
- GH sufficiency (GH level > 7 ug/l following any routine GH stimulation test).
- Written informed consent of both parents (legal guardians) and oral/written consent of subject due to age specific information.
Who cannot join
- Subjects presenting with any of the following will not be included in the trial:
- Other endocrine diseases except for well substituted hypothyroidism.
- Severe chronic diseases or medication that might influence linear growth or insulin sensitivity (e.g. Glucocorticoids).
- Positive GAD and IA-2 antibodies (for type 1 diabetes).
- History of malignancy
- Children who meet all of the following 4 criteria:
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- actual body height < -2,5 SDS (Brandt/Reinken) and parent adjusted target height < -1 SDS (Hermanussen and Cole, 2003)
- length and/or body weight retardations adjusted to gestational age at birth < -2,0 SDS (Lawrence et al., 1989, Voigt et al., 1996)
- children with chronological age > = 4 years and
- growth velocity < 0 SDS during the last year before inclusion.
- Chromosomal aberrations or syndromes.
- Suspected non-compliance or impossibility to follow the two or three year treatment schedule, respectively (e.g. social implications).
- Severe hemiparesis and severe CNS defects
- Retinopathia > third degree or laser treatment as newborns.
- Participation in any other clinical trial during active treatment phase.
- Other severe acute or chronic medical or psychiatric condition or clinically relevant laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
Pfizer Investigational Site
Chemnitz, 09009
Pfizer Investigational Site
Cologne, 50937
Pfizer Investigational Site
Erlangen, 91054
Pfizer Investigational Site
Freiburg im Breisgau, 79106
Pfizer Investigational Site
Heidelberg, 69120
Pfizer Investigational Site
Homburg, 66424
Pfizer Investigational Site
Leipzig, 04103
Pfizer Investigational Site
Tübingen, 72076
About this study
Official title: Somatropin Therapy For Short Children Born Of Premature Gestation, A Controlled, Prospective Randomized, Multicenter Study With An Untreated Control Group.
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.
- Being tested
- Somatropin, Control Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. Children randomized to the control group will get the possibility to continue treatment for a further year. The study will end after 2 and 3 years of observation, respectively.
Control ArmOther
Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. The study will end after 2 and 3 years of observation, respectively. Children randomized to the control group will get the possibility to continue treatment for a further year.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | Not described Receives: Drug: Somatropin; Other: Control Arm |
| Control Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Height Standard Deviation Score (SDS) After 1 Year
Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Measured: Baseline to 1 year (Month 12)
Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year
Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Measured: Baseline to 1 year (Month 12)
Secondary outcomes (21)
Change From Baseline in Growth Velocity After 1 Year and After 2 Years
Growth velocity measured as centimeters per year.
Measured: Baseline, Month 12, Month 24
Change From Baseline in Growth Velocity SDS After 2 Years
Change in Growth Velocity SDS after 2 years (24 months) where SDS = growth velocity minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Measured: Baseline, Month 24
Change From Baseline in Height After 1 Year and After 2 Years
Measured: Baseline, Month 12, Month 24
Change From Baseline in Height SDS After 2 Years
Change in Height SDS after 2 years (24 months) where SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Measured: Baseline, Month 24
Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps
Body composition measured as skinfold thickness at tricep in millimeters (mm); measured halfway down the left upper arm with arm hanging in relaxed position at participant's side.
Measured: Baseline, Month 12, Month 24
Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular
Body composition measured as subscapular skinfold thickness in millimeters (mm); measured laterally just below the angle of the left scapula.
Measured: Baseline, Month 12, Month 24
Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac
Body composition measured as suprailiac skinfold thickness in millimeters (mm); measured just above the iliac crest in the middle-axillary line.
Measured: Baseline, Month 12, Month 24
Change From Baseline in Volumetric Cortical Bone Mineral Density (BMD) Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and After 2 Years
Volumetric Cortical BMD measured as milligrams per cubic millimeter (mg/mm3). BMD (proximal radius) SDS (number of standard deviations a participant's BMD differs from the average BMD of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.
Measured: Baseline, Month 12, Month 24
Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Cross-sectional Area (CSA)
Bone structure Cortical CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.
Measured: Baseline, Month 12, Month 24
Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and 2 Years: Total Cross-sectional Area (CSA)
Bone structure Total CSA measured as millimeters squared (mm2). Total CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.
Measured: Baseline, Month 12, Month 24
Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Muscle Cross-sectional Area (CSA)
Bone structure Muscle CSA measured as millimeters squared (mm2). CSA (proximal radius) SDS (number of standard deviations a participant's CSA differs from the average CSA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.
Measured: Baseline, Month 12, Month 24
Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Thickness (CT)
Cortical Thickness measured as millimeters (mm). CT (proximal radius) SDS (number of standard deviations a participant's CT differs from the average CT of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.
Measured: Baseline, Month 12, Month 24
Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Marrow Area (MA)
Marrow Area measured as millimeters squared (mm2). MA (proximal radius) SDS (number of standard deviations a participant's MA differs from the average MA of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.
Measured: Baseline, Month 12, Month 24
Change From Baseline in Bone Stability Using pQCT After 1 Year and After 2 Years: Strength-strain Index (SSI)
Bone stability expressed as polar SSI in cubic millimeters (mm3). SSI (proximal radius) SDS (number of standard deviations a participant's SSI differs from the average SSI of their age and sex). Baseline and post-baseline SDS values transformed to age and sex specific z-score (Ln(test result/M)]/S); Ln=natural logarithm; M=age- or height-) and sex-specific mean value; S=age-(or height-) and sex-specific coefficient of variation) then change from baseline is calculated. Positive values are above the average for participant's age and sex; negative values are below the average.
Measured: Baseline, Month 12, Month 24
Change From Baseline in Muscle Strength: Hand Grip SDS After 1 Year and After 2 Years
Muscle strength determined by measuring grip force (kilograms) using hand grip dynamometer for participants ≥6 years of age. Baseline and post-baseline SDS values transformed to age and sex specific z-score. Change in hand grip calculated as SDS where SDS = hand grip minus mean (age- and sex-matched reference) divided by SD (age- and sex-matched reference). Positive values are above the average for participant's age and sex; negative values are below the average.
Measured: Baseline, Month 12, Month 24
Number of Participants With Change in Insulin Sensitivity: Somatropin
Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Somatropin treatment group=Month 24). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to >140 mg/dL; capillary (blood) with range minimum 120 mg/dL to >120 mg/dL; or method not known with range minimum 120 mg/dL to >120 mg/dL.
Measured: Baseline, Month 24
Number of Participants With Change in Insulin Sensitivity: Control Arm
Insulin sensitivity calculated as incidence of pathological glucose intolerance assessed prior to randomization (Screening Day -3 to Baseline Day 0) and at final visit (final visit: Control Arm=Month 36). Pathological glucose intolerance (oral glucose tolerance test) measured as venous (blood or plasma) with range minimum 120 milligrams per deciliter (mg/dL) to >140 mg/dL; capillary (blood) with range minimum 120 mg/dL to >120 mg/dL; or method not known with range minimum 120 mg/dL to >120 mg/dL.
Measured: Baseline, Month 36
Growth Curve Comparison Based on Height SDS
Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Measured: Month 12, Month 24
Growth Curve Comparison Based on Height SDS: Control Arm
Growth curve comparison with height SDS in centimeters as the dependent variable; SDS = height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference). Control Arm final visit=Month 36.
Measured: Month 36
Growth Curve Comparison Based on Height
Growth curve comparison with height in centimeters as the dependent variable.
Measured: Month 12, Month 24
Growth Curve Comparison Based on Height: Control Arm
Growth curve comparison with height in centimeters as the dependent variable.
Measured: Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionMar 2008
- Study completionMar 2010
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 Growth Hormone TherapyStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174460
- Sponsor's protocol ID
- A6281273
- Acronym
- AGA
- Status last verified
- Mar 2017
- First submitted
- 12 Sep 2005
- Last updated
- 5 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatropin Therapy For Short Children Born Of Premature Gestation, A Controlled, Prospective Randomized, Multicenter Study With An Untreated Control Group.
- ClinicalTrials.gov ID
- NCT00174460
- Acronym / sponsor ID
- AGA / A6281273
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 12 May 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Drug: Somatropin, Other: Control Arm |
| Control Arm | No intervention | – |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- Prepubertal caucasian boys between 4 and 10 years of age and girls between 4 and 9 years of age.
- Girls: Tanner stage 1 breast development
- Boys: Testis volume <= 3ml
- Tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on growth velocity, insulin sensitivity and body composition).
Key exclusion criteria (16 listed)
- Other endocrine diseases except for well substituted hypothyroidism.
- Severe chronic diseases or medication that might influence linear growth or insulin sensitivity (e.g. Glucocorticoids).
- Positive GAD and IA-2 antibodies (for type 1 diabetes).
- History of malignancy
- Children who meet all of the following 4 criteria:
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 |
|---|---|---|
| SomatropinControlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. Children randomized to the control group will get the possibility to continue treatment for a further year. The study will end after 2 and 3 years of observation, respectively. | Drug | Treatment Arm |
| Control ArmControlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. The study will end after 2 and 3 years of observation, respectively. Children randomized to the control group will get the possibility to continue treatment for a further year. | Other | Treatment Arm |
Primary outcome
Change in Height Standard Deviation Score (SDS) After 1 Year
Time frame: Baseline to 1 year (Month 12)
Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year
Time frame: Baseline to 1 year (Month 12)
Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
21 secondary outcomes
Change From Baseline in Growth Velocity After 1 Year and After 2 Years
Time frame: Baseline, Month 12, Month 24
Change From Baseline in Growth Velocity SDS After 2 Years
Time frame: Baseline, Month 24
Change From Baseline in Height After 1 Year and After 2 Years
Time frame: Baseline, Month 12, Month 24
Change From Baseline in Height SDS After 2 Years
Time frame: Baseline, Month 24
Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps
Time frame: Baseline, Month 12, Month 24
Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular
Time frame: Baseline, Month 12, Month 24
Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac
Time frame: Baseline, Month 12, Month 24
Change From Baseline in Volumetric Cortical Bone Mineral Density (BMD) Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and After 2 Years
Time frame: Baseline, Month 12, Month 24
Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Cross-sectional Area (CSA)
Time frame: Baseline, Month 12, Month 24
Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and 2 Years: Total Cross-sectional Area (CSA)
Time frame: Baseline, Month 12, Month 24
Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Muscle Cross-sectional Area (CSA)
Time frame: Baseline, Month 12, Month 24
Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Thickness (CT)
Time frame: Baseline, Month 12, Month 24
Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Marrow Area (MA)
Time frame: Baseline, Month 12, Month 24
Change From Baseline in Bone Stability Using pQCT After 1 Year and After 2 Years: Strength-strain Index (SSI)
Time frame: Baseline, Month 12, Month 24
Change From Baseline in Muscle Strength: Hand Grip SDS After 1 Year and After 2 Years
Time frame: Baseline, Month 12, Month 24
Number of Participants With Change in Insulin Sensitivity: Somatropin
Time frame: Baseline, Month 24
Number of Participants With Change in Insulin Sensitivity: Control Arm
Time frame: Baseline, Month 36
Growth Curve Comparison Based on Height SDS
Time frame: Month 12, Month 24
Growth Curve Comparison Based on Height SDS: Control Arm
Time frame: Month 36
Growth Curve Comparison Based on Height
Time frame: Month 12, Month 24
Growth Curve Comparison Based on Height: Control Arm
Time frame: Month 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Somatropin in people with Growth Hormone Therapy and Infant, Very Low Birth Weight, run by Pfizer at 8 sites in Germany.
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 11 inclusion and 16 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 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. 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 12 May 2009). 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?
Change in Height Standard Deviation Score (SDS) After 1 Year (time frame: Baseline to 1 year (Month 12)). The study lists 2 primary outcomes in all. 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 5 Apr 2017.