Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy (SGA-POWER)

This study has been terminated.
(The study terminated on 19-Jan-2011 due to insufficient recruitment of patients. No safety reasons contributed to the termination of the study.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00625872
First received: February 19, 2008
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Growth Hormone Therapy
Infant, Small for Gestational Age
Drug: Somatropin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neuromuscular Changes In Small For Gestational Age (SGA) Children During Somatropin Therapy - A Prospective Randomized, Controlled, Open-Label Multicenter Trial

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Vmax was measured by Leonardo Jumping Platform during two-leg jump.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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].

  • 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 ] [ Designated as safety issue: No ]
    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].

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Vmax was measured by Leonardo Jumping Platform during one leg jump.

  • Change From Baseline in Five-chair Rising Test- Peak Jump Power (PJP) at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Mean Upper Arm Circumference [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ] [ Designated as safety issue: No ]
  • Mean Thigh Circumference [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ] [ Designated as safety issue: No ]
    Thigh measurements were taken as a mean of 3 consecutive measurements at upper thigh about an inch down from the crotch line.

  • Mean Calf Circumference [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ] [ Designated as safety issue: No ]
    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.

  • Mean Height at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.

  • Mean Height at Months 12 and 18 [ Time Frame: Month 12 and Month 18 ] [ Designated as safety issue: No ]
    Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer.

  • Mean Growth Velocity at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Growth velocity measures the annual rate of increase in height.

  • Mean Growth Velocity at Months 12 and 18 [ Time Frame: Month 12 and Month 18 ] [ Designated as safety issue: No ]
    Growth velocity measures the annual rate of increase in height.

  • Mean Height-Standard Deviation Score (SDS) at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.

  • Mean Height-Standard Deviation Score (SDS) at Months 12 and 18 [ Time Frame: Month 12 and Month 18 ] [ Designated as safety issue: No ]
    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.

  • Mean Growth Velocity-Standard Deviation Score (SDS) at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.

  • Mean Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18 [ Time Frame: Month 12 and Month 18 ] [ Designated as safety issue: No ]
  • Change From Baseline in Height-Standard Deviation Score (SDS) at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Height-Standard Deviation Score (SDS) at Months 12 and 18 [ Time Frame: Baseline, Month 12 and Month 18 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.

  • Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18 [ Time Frame: Baseline, Month 12 and Month 18 ] [ Designated as safety issue: No ]
    Growth velocity measures the annual rate of increase in height. The SDS indicates how similar the participant is to the reference population.

  • Sitting Height-Standard Deviation Score (SDS) [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ] [ Designated as safety issue: No ]
    Sitting height was measured using a stadiometer with a specialized chair. The SDS indicates how similar the participant was to the reference population.

  • Body Mass Index-Standard Deviation Score (BMI-SDS) [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Head Circumference at Months 6, 12 and 18 [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Head Circumference-Standard Deviation Score (SDS) at Months 6, 12 and 18 [ Time Frame: Baseline, Month 6, Month 12 and Month 18 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Month 6 [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Months 12 and 18 [ Time Frame: Baseline, Month 12 and Month 18 ] [ Designated as safety issue: No ]
    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.


Enrollment: 23
Study Start Date: July 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Group
Somatropin for 12 months
Drug: Somatropin
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.
Control Group
In the first 6 months no intervention, afterwards Somatropin for 12 months
Drug: Somatropin
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.

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625872

Locations
Germany
Pfizer Investigational Site
Berlin, Germany, 13353
Pfizer Investigational Site
Bonn, Germany, 53113
Pfizer Investigational Site
Datteln, Germany, 45711
Pfizer Investigational Site
Dresden, Germany, 01307
Pfizer Investigational Site
Erlangen, Germany, 91054
Pfizer Investigational Site
Essen, Germany, 45122
Pfizer Investigational Site
Heidelberg, Germany, 69120
Pfizer Investigational Site
Kiel, Germany, 24105
Pfizer Investigational Site
Koeln, Germany, 50937
Pfizer Investigational Site
Muenchen, Germany, 80337
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00625872     History of Changes
Other Study ID Numbers: A6281283
Study First Received: February 19, 2008
Results First Received: January 27, 2012
Last Updated: January 27, 2012
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices (BfArM)

ClinicalTrials.gov processed this record on July 24, 2014