Growth Hormone TherapyPhase 3SGA-POWERNCT00625872
Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy
A Phase 3 study testing Somatropin in people with Growth Hormone Therapy and Infant, Small for Gestational Age, run by Pfizer at 10 sites in Germany.
Trial summary
The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Growth Hormone Therapy, Infant, Small for Gestational Age
- What is being tested?
- Somatropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 10 sitesGermany
- Study dates
- Jul 2008to Mar 2011
- Phase
- Phase 3
- 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 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pre-pubertal boys between 6 and 10 years of age or girls between 6 and 9 years of age.
- Birth length- and/or birth weight-SDS adjusted to gestational age < -2.0 (Voigt et al. 2002, Voigt et al. 2006 or Lawrence et al. 1989).
- Current height-SDS < -2.5 (Brandt/Reinken 1992) and parental adjusted height-SDS below -1 (Hermanussen and Cole 2003).
- Growth velocity SDS < 0 during the last year before inclusion (Brandt/Reinken 1988).
Who cannot join
- Severe SGA (birth weight or length < -4 SD) and clinically relevant dysmorphic features.
- Severe pre-maturity (GA < 32 weeks of gestation).
- Severe perinatal complications like asphyxia, sepsis, necrotizing enterocolitis (NEC), respiratory distress syndrome, if associated with long-term sequelae (like short bowel syndrome, bronchopulmonary dysplasia (BPD), cerebral palsy etc).
- Inability to perform one- or two leg jumps from a standing position.
- Prior GH treatment.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Pfizer Investigational Site
Berlin, 13353
Pfizer Investigational Site
Bonn, 53113
Pfizer Investigational Site
Cologne, 50937
Pfizer Investigational Site
Datteln, 45711
Pfizer Investigational Site
Dresden, 01307
Pfizer Investigational Site
Erlangen, 91054
Pfizer Investigational Site
Essen, 45122
Pfizer Investigational Site
Heidelberg, 69120
Pfizer Investigational Site
Kiel, 24105
Pfizer Investigational Site
München, 80337
About this study
Official title: Neuromuscular Changes In Small For Gestational Age (SGA) Children During Somatropin Therapy - A Prospective Randomized, Controlled, Open-Label Multicenter Trial
The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance.
- Being tested
- Somatropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.
SomatropinDrug
Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | Somatropin for 12 months Receives: Drug: Somatropin |
| Control Group | Other | In the first 6 months no intervention, afterwards Somatropin for 12 months Receives: Drug: Somatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6
Peak jump power (PJP) was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.
Measured: Baseline and Month 6
Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6
PJP was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.
Measured: Baseline and Month 6
Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6
PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.
Measured: Baseline and Month 6
Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6
PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.
Measured: Baseline and Month 6
Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6
Vmax was measured by Leonardo Jumping Platform during two-leg jump.
Measured: Baseline and Month 6
Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Per Protocol (PP) Population at Month 6
Vmax was measured by Leonardo Jumping Platform during two-leg jump.
Measured: Baseline and Month 6
Secondary outcomes (44)
Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6
K-ABC was assessed in children between 2.5-12.5 years. Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests. Achievement subtests: expressive vocabulary, faces\&places, arithmetic, riddles, reading/decoding, reading/comprehension. Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite. Scores were rated as upper extreme [greater than (>) 131], above average (116-130), average (85-115), below average (70-84), lower extreme [less than (<) 69].
Measured: Baseline and Month 6
Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Months 12 and 18
K-ABC was assessed in children between 2.5-12.5 years. Comprised of 16 subtests; 10 mental processing (intelligence) and 6 achievement subtests. Achievement subtests: expressive vocabulary, faces\&places, arithmetic, riddles, reading/decoding, reading/comprehension. Sixteen subtests were weighted accordingly to form 5 global scales: sequential processing, simultaneous processing, achievement, non-verbal and mental processing composite. Scores were rated as upper extreme [greater than (>) 131], above average (116-130), average (85-115), below average (70-84), lower extreme [less than (<) 69].
Measured: Baseline, Month 12 and Month 18
Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Month 6
The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); "Sustained Attention", change of reaction (Flexibility); "Divided Attention", controlled reaction disposition (Go/No go) and "Vigilance". It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results.
Measured: Baseline and Month 6
Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Months 12 and 18
The KITAP is a computer aided standardized neuro-cognitive development test which allows examination of a wide range of attention and executive functions such as shift of attention (Distractibility); simple reaction time (Alertness); "Sustained Attention", change of reaction (Flexibility); "Divided Attention", controlled reaction disposition (Go/No go) and "Vigilance". It has been designed appropriately for children between the age of 6 to 10 years to allow optimal motivation during testing and to increase validity of results.
Measured: Baseline, Month 12 and Month 18
Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Month 6
NVLT was assessed for visual memorization that was difficult to verbalize. Test recorded instability index, T-scores[sum of differences of correct {C} - incorrect {IC} "Yes" answers(1);sum of C "Yes" answers(2);sum of IC "Yes" answers(3);sum of differences of C-IC "Yes" answers with high associative items{ 87%-95%}(4);sum of differences of C-IC "Yes" answers with low associative items{ 54%-64%}(5); difference between difference values for high and low associative items(6)].Scores were rated as below average(<40), average(40-60), above average(>60) and working time ranging between 9-12 minutes.
Measured: Baseline and Month 6
Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Months 12 and 18
NVLT was assessed for visual memorization that was difficult to verbalize. Test recorded instability index, T-scores[sum of differences of correct {C} - incorrect {IC} "Yes" answers(1);sum of C "Yes" answers(2);sum of IC "Yes" answers(3);sum of differences of C-IC "Yes" answers with high associative items{ 87%-95%}(4);sum of differences of C-IC "Yes" answers with low associative items{ 54%-64%}(5); difference between difference values for high and low associative items(6)].Scores were rated as below average(<40), average(40-60), above average(>60) and working time ranging between 9-12 minutes.
Measured: Baseline, Month 12 and Month 18
Change From Baseline in Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) at Months 6, 12 and 18
CBCL was standardized for children ages 4 to 18 years and measured child internalizing and externalizing behaviors and total problems. The 4-18 years' checklist contains 140 questions and responses were recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The range of possible values was 0-280 (0=good to 280=worst).
Measured: Baseline, Month 6, Month 12 and Month 18
Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; One-leg-jump) at Months 6, 12 and 18
PJP was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during one leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.
Measured: Baseline, Month 6 , Month 12 and Month 18
Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; One-leg-jump) at Months 6, 12 and 18
PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during one leg jump. The SDS indicates how similar the participant was to the reference population.
Measured: Baseline, Month 6, Month 12 and Month 18
Change From Baseline in Maximum Jump Velocity (Vmax; One-leg-jump) at Months 6, 12 and 18
Vmax was measured by Leonardo Jumping Platform during one leg jump.
Measured: Baseline, Month 6, Month 12 and Month 18
Change From Baseline in Five-chair Rising Test- Peak Jump Power (PJP) at Month 6
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJP is defined as the peak of the calculated power (force multiplied by velocity).
Measured: Baseline and Month 6
Change From Baseline in Five-chair Rising Test-Peak Jump Power (PJP) at Months 12 and 18
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJP is defined as the peak of the calculated power (force multiplied by velocity).
Measured: Baseline, Month 12 and Month 18
Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Month 6
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.
Measured: Baseline and Month 6
Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Months 12 and 18
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.
Measured: Baseline, Month 12 and Month 18
Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Month 6
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). Vmax is defined as the maximum jump velocity.
Measured: Baseline and Month 6
Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Months 12 and 18
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: five repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over the chest (time to perform the tasks, maximal PJP, maximal velocity and maximal PJF). Vmax is defined as the maximum jump velocity.
Measured: Baseline, Month 12 and Month 18
Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Month 6
Chair rising test is performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: 5 repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over chest (time to perform tasks, maximal PJP, maximal velocity and maximal PJF). Time to perform task includes: Average (avg) rise time which is avg time to perform 1 rise, avg time per test is the avg time to perform 1 test (rise and sitting down) and total time to perform 5 tests.
Measured: Baseline and Month 6
Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Months 12 and 18
Chair rising test is performance test (total power output) to measure neuromuscular function of complex movement in standing up. Test allows diagnostics of movement deficits using Leonardo jump plate. Five stand up test: 5 repetitions of rising from a chair on jump plate as quickly as possible with arms crossed over chest (time to perform tasks, maximal PJP, maximal velocity and maximal PJF). Time to perform task includes: Average (avg) rise time which is avg time to perform 1 rise, avg time per test is the avg time to perform 1 test (rise and sitting down) and total time to perform 5 tests.
Measured: Baseline, Month 12 and Month 18
Change From Baseline in One-chair Rising Test-Peak Jump Power (PJP) at Months 6, 12 and 18
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising). PJP is defined as the peak of the calculated power (force multiplied by velocity).
Measured: Baseline, Month 6 , Month 12 and Month 18
Change From Baseline in One-chair Rising Test-Peak Jump Force (PJF) at Months 6, 12 and 18
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising). PJF is the maximum force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms as high as possible with the head and chest.
Measured: Baseline, Month 6 , Month 12 and Month 18
Change From Baseline in One-chair Rising Test (Time to Perform the Tasks) at Months 6, 12 and 18
The Chair rising test is a performance test (total power output) to measure neuromuscular function of complex movement to stand up. Test allows diagnostics of movement deficits using Leonardo jump plate. One stand up test: rising from a chair on the jump plate as quickly as possible with arms crossed over the chest (analysis of time, PJP, PJF and time of fastest rising).
Measured: Baseline, Month 6 , Month 12 and Month 18
Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Month 6
MIGF was assessed using standard adjustable Jamar dynamometer. MIGF (in Newtons) was calculated by multiplying the dynamometer reading (in kilograms) by a factor of 9.81. The SDS indicates how similar the participant was to the reference population.
Measured: Baseline and Month 6
Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Months 12 and 18
MIGF was assessed using standard adjustable Jamar dynamometer. MIGF (in Newtons) was calculated by multiplying the dynamometer reading (in kilograms) by a factor of 9.81. The SDS indicates how similar the participant was to the reference population.
Measured: Baseline, Month 12 and Month 18
Mean Upper Arm Circumference
Measured: Baseline, Month 6, Month 12 and Month 18
Mean Thigh Circumference
Thigh measurements were taken as a mean of 3 consecutive measurements at upper thigh about an inch down from the crotch line.
Measured: Baseline, Month 6, Month 12 and Month 18
Mean Calf Circumference
Calf measurements were taken as a mean of 3 consecutive measurements at largest part of calf muscle, usually about 4 inches down from below the knee.
Measured: Baseline, Month 6, Month 12 and Month 18
Mean Height at Month 6
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.
Measured: Month 6
Mean Height at Months 12 and 18
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.
Measured: Month 12 and Month 18
Mean Growth Velocity at Month 6
Growth velocity measures the annual rate of increase in height.
Measured: Month 6
Mean Growth Velocity at Months 12 and 18
Growth velocity measures the annual rate of increase in height.
Measured: Month 12 and Month 18
Mean Height-Standard Deviation Score (SDS) at Month 6
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.
Measured: Month 6
Mean Height-Standard Deviation Score (SDS) at Months 12 and 18
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.
Measured: Month 12 and Month 18
Mean Growth Velocity-Standard Deviation Score (SDS) at Month 6
Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.
Measured: Month 6
Mean Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18
Measured: Month 12 and Month 18
Change From Baseline in Height-Standard Deviation Score (SDS) at Month 6
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.
Measured: Baseline and Month 6
Change From Baseline in Height-Standard Deviation Score (SDS) at Months 12 and 18
Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. The SDS indicates how similar the participant was to the reference population.
Measured: Baseline, Month 12 and Month 18
Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Month 6
Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.
Measured: Baseline and Month 6
Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18
Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.
Measured: Baseline, Month 12 and Month 18
Sitting Height-Standard Deviation Score (SDS)
Sitting height was measured using a stadiometer with a specialized chair. The SDS indicates how similar the participant was to the reference population.
Measured: Baseline, Month 6, Month 12 and Month 18
Body Mass Index-Standard Deviation Score (BMI-SDS)
The BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg) divided by the height (m) squared. The SDS indicates how similar the participant was to the reference population.
Measured: Baseline, Month 6, Month 12 and Month 18
Change From Baseline in Head Circumference at Months 6, 12 and 18
The maximum head circumference (usually horizontal just above the eyebrow ridges), was measured from just above the glabella area to the area near the top of the occipital bone (opisthocranion).
Measured: Baseline, Month 6, Month 12 and Month 18
Change From Baseline in Head Circumference-Standard Deviation Score (SDS) at Months 6, 12 and 18
The maximum head circumference (usually horizontal just above the eyebrow ridges), was measured from just above the glabella area to the area near the top of the occipital bone (opisthocranion). The SDS indicates how similar the participant was to the reference population.
Measured: Baseline, Month 6, Month 12 and Month 18
Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Month 6
Triceps, supra-iliac and subscapular skinfolds were measured on the right side of the body to the nearest 0.1 mm with a Holtain skinfold caliper. The measurement was performed at the left side of the participant. Triceps skinfold thickness was measured halfway down the left upper arm, while the arm was hanging relaxed at the participant's side. Suprascapular skinfold was measured laterally just below the angle of the left scapula. Suprailiac skinfold was measured just above the iliac crest in the middle-axillary line. SDS indicates how similar the participant was to the reference population.
Measured: Baseline and Month 6
Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Months 12 and 18
Triceps, supra-iliac and subscapular skinfolds were measured on the right side of the body to the nearest 0.1 mm with a Holtain skinfold caliper. The measurement was performed at the left side of the participant. Triceps skinfold thickness was measured halfway down the left upper arm, while the arm was hanging relaxed at the participant's side. Suprascapular skinfold was measured laterally just below the angle of the left scapula. Suprailiac skinfold was measured just above the iliac crest in the middle-axillary line. SDS indicates how similar the participant was to the reference population.
Measured: Baseline, Month 12 and Month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: The study terminated on 19-Jan-2011 due to insufficient recruitment of patients. No safety reasons contributed to the termination of the study.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT00625872
- Sponsor's protocol ID
- A6281283
- Acronym
- SGA-POWER
- Status last verified
- Jan 2012
- First submitted
- 19 Feb 2008
- Last updated
- 29 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Changes In Small For Gestational Age (SGA) Children During Somatropin Therapy - A Prospective Randomized, Controlled, Open-Label Multicenter Trial
- ClinicalTrials.gov ID
- NCT00625872
- Acronym / sponsor ID
- SGA-POWER / A6281283
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study terminated on 19-Jan-2011 due to insufficient recruitment of patients. No safety reasons contributed to the termination of the study.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Posted 29 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Drug: SomatropinSomatropin for 12 months |
| Control Group | Other | Drug: SomatropinIn the first 6 months no intervention, afterwards Somatropin for 12 months |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pre-pubertal boys between 6 and 10 years of age or girls between 6 and 9 years of age.
- Birth length- and/or birth weight-SDS adjusted to gestational age < -2.0 (Voigt et al. 2002, Voigt et al. 2006 or Lawrence et al. 1989).
- Current height-SDS < -2.5 (Brandt/Reinken 1992) and parental adjusted height-SDS below -1 (Hermanussen and Cole 2003).
- Growth velocity SDS < 0 during the last year before inclusion (Brandt/Reinken 1988).
Key exclusion criteria (5 listed)
- Severe SGA (birth weight or length < -4 SD) and clinically relevant dysmorphic features.
- Severe pre-maturity (GA < 32 weeks of gestation).
- Severe perinatal complications like asphyxia, sepsis, necrotizing enterocolitis (NEC), respiratory distress syndrome, if associated with long-term sequelae (like short bowel syndrome, bronchopulmonary dysplasia (BPD), cerebral palsy etc).
- Inability to perform one- or two leg jumps from a standing position.
- Prior GH treatment.
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 |
|---|---|---|
| SomatropinPatients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months. | Drug | Treatment Group |
| SomatropinPatients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months. | Drug | Control Group |
Primary outcome
Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6
Time frame: Baseline and Month 6
Peak jump power (PJP) was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.
Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6
Time frame: Baseline and Month 6
PJP was defined as the peak of the calculated power (force multiplied by velocity). It was measured by Leonardo Jumping Platform during two-leg jump. The participant performs 3 jumps and the highest peak (PJP) of the 3 recordings was selected for further calculations. The SDS indicates how similar the participant was to the reference population.
Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6
Time frame: Baseline and Month 6
PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.
Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6
Time frame: Baseline and Month 6
PJF was defined as the maximum of force of the ascending part of the jump which the participant performed as a counter-movement jump with freely moving arms and as high as possible with the head and chest. It was measured by Leonardo Jumping Platform during two-leg jump. The SDS indicates how similar the participant was to the reference population.
Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6
Time frame: Baseline and Month 6
Vmax was measured by Leonardo Jumping Platform during two-leg jump.
Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Per Protocol (PP) Population at Month 6
Time frame: Baseline and Month 6
Vmax was measured by Leonardo Jumping Platform during two-leg jump.
44 secondary outcomes
Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at Months 12 and 18
Time frame: Baseline, Month 12 and Month 18
Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at Months 12 and 18
Time frame: Baseline, Month 12 and Month 18
Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Months 12 and 18
Time frame: Baseline, Month 12 and Month 18
Change From Baseline in Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) at Months 6, 12 and 18
Time frame: Baseline, Month 6, Month 12 and Month 18
Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; One-leg-jump) at Months 6, 12 and 18
Time frame: Baseline, Month 6 , Month 12 and Month 18
Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; One-leg-jump) at Months 6, 12 and 18
Time frame: Baseline, Month 6, Month 12 and Month 18
Change From Baseline in Maximum Jump Velocity (Vmax; One-leg-jump) at Months 6, 12 and 18
Time frame: Baseline, Month 6, Month 12 and Month 18
Change From Baseline in Five-chair Rising Test- Peak Jump Power (PJP) at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Five-chair Rising Test-Peak Jump Power (PJP) at Months 12 and 18
Time frame: Baseline, Month 12 and Month 18
Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Months 12 and 18
Time frame: Baseline, Month 12 and Month 18
Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Months 12 and 18
Time frame: Baseline, Month 12 and Month 18
Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Months 12 and 18
Time frame: Baseline, Month 12 and Month 18
Change From Baseline in One-chair Rising Test-Peak Jump Power (PJP) at Months 6, 12 and 18
Time frame: Baseline, Month 6 , Month 12 and Month 18
Change From Baseline in One-chair Rising Test-Peak Jump Force (PJF) at Months 6, 12 and 18
Time frame: Baseline, Month 6 , Month 12 and Month 18
Change From Baseline in One-chair Rising Test (Time to Perform the Tasks) at Months 6, 12 and 18
Time frame: Baseline, Month 6 , Month 12 and Month 18
Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Months 12 and 18
Time frame: Baseline, Month 12 and Month 18
Mean Upper Arm Circumference
Time frame: Baseline, Month 6, Month 12 and Month 18
Mean Thigh Circumference
Time frame: Baseline, Month 6, Month 12 and Month 18
Mean Calf Circumference
Time frame: Baseline, Month 6, Month 12 and Month 18
Mean Height at Month 6
Time frame: Month 6
Mean Height at Months 12 and 18
Time frame: Month 12 and Month 18
Mean Growth Velocity at Month 6
Time frame: Month 6
Mean Growth Velocity at Months 12 and 18
Time frame: Month 12 and Month 18
Mean Height-Standard Deviation Score (SDS) at Month 6
Time frame: Month 6
Mean Height-Standard Deviation Score (SDS) at Months 12 and 18
Time frame: Month 12 and Month 18
Mean Growth Velocity-Standard Deviation Score (SDS) at Month 6
Time frame: Month 6
Mean Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18
Time frame: Month 12 and Month 18
Change From Baseline in Height-Standard Deviation Score (SDS) at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Height-Standard Deviation Score (SDS) at Months 12 and 18
Time frame: Baseline, Month 12 and Month 18
Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Month 6
Time frame: Baseline and Month 6
Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18
Time frame: Baseline, Month 12 and Month 18
Sitting Height-Standard Deviation Score (SDS)
Time frame: Baseline, Month 6, Month 12 and Month 18
Body Mass Index-Standard Deviation Score (BMI-SDS)
Time frame: Baseline, Month 6, Month 12 and Month 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2012.
- 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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Somatropin in people with Growth Hormone Therapy and Infant, Small for Gestational Age, run by Pfizer at 10 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 29 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6 (time frame: Baseline and Month 6). The study lists 6 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 29 Feb 2012.