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AzTrials

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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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
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

Other trials in Germany

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 groups in NCT00625872
Study groupRoleWhat they receive
Treatment GroupActive comparatorSomatropin for 12 months
Receives: Drug: Somatropin
Control GroupOtherIn 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. Mean Upper Arm Circumference

    Measured: Baseline, Month 6, Month 12 and Month 18

  25. 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

  26. 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

  27. Mean Height at Month 6

    Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.

    Measured: Month 6

  28. 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

  29. Mean Growth Velocity at Month 6

    Growth velocity measures the annual rate of increase in height.

    Measured: Month 6

  30. Mean Growth Velocity at Months 12 and 18

    Growth velocity measures the annual rate of increase in height.

    Measured: Month 12 and Month 18

  31. 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

  32. 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

  33. 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

  34. Mean Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18

    Measured: Month 12 and Month 18

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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.

  1. First posted28 Feb 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionMar 2011
  4. 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

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)
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
Data monitoring committee
No

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.

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