Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

Condition(s) targeted: Growth Hormone Therapy; Infant, Small for Gestational Age

Intervention: Somatropin (Drug); Somatropin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: Neuromuscular Changes In Small For Gestational Age (SGA) Children During Somatropin Therapy - A Prospective Randomized, Controlled, Open-Label Multicenter Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; Two-leg-jump) in Per Protocol (PP) Population at 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

Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; Two-leg-jump) in Per Protocol (PP) Population at Month 6

Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Full Analysis Set (FAS) Population at Month 6

Change From Baseline in Maximum Jump Velocity (Vmax; Two-leg-jump) in Per Protocol (PP) Population at Month 6

Secondary outcome:

Change From Baseline in Intellectual Performance of Children Using Kaufmann-Assessment Battery for Children (K-ABC) Test Global Scales at 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

Change From Baseline in Intellectual Performance of Children Using Kinderversion Der Testbatterie Zur Aufmerksamkeitsprüfung für Kinder (KITAP) Test at 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

Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Month 6

Change From Baseline in Intellectual Performance of Children Using Non-verbal Learning Test (NVLT) at Months 12 and 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

Change From Baseline in Peak Jump Power Standard Deviation Score (PJP-SDS; One-leg-jump) at Months 6, 12 and 18

Change From Baseline in Peak Jump Force Standard Deviation Score (PJF-SDS; One-leg-jump) at Months 6, 12 and 18

Change From Baseline in Maximum Jump Velocity (Vmax; One-leg-jump) at Months 6, 12 and 18

Change From Baseline in Five-chair Rising Test- Peak Jump Power (PJP) at Month 6

Change From Baseline in Five-chair Rising Test-Peak Jump Power (PJP) at Months 12 and 18

Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Month 6

Change From Baseline in Five-chair Rising Test-Peak Jump Force (PJF) at Months 12 and 18

Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Month 6

Change From Baseline in Five-chair Rising Test-Maximum Jump Velocity (Vmax) at Months 12 and 18

Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Month 6

Change From Baseline in Five-chair Rising Test (Time to Perform the Tasks) at Months 12 and 18

Change From Baseline in One-chair Rising Test-Peak Jump Power (PJP) at Months 6, 12 and 18

Change From Baseline in One-chair Rising Test-Peak Jump Force (PJF) at Months 6, 12 and 18

Change From Baseline in One-chair Rising Test (Time to Perform the Tasks) at Months 6, 12 and 18

Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Month 6

Change From Baseline in Maximal Isometric Grip Force-Standard Deviation Score (MIGF-SDS) at Months 12 and 18

Mean Upper Arm Circumference

Mean Thigh Circumference

Mean Calf Circumference

Mean Height at Month 6

Mean Height at Months 12 and 18

Mean Growth Velocity at Month 6

Mean Growth Velocity at Months 12 and 18

Mean Height-Standard Deviation Score (SDS) at Month 6

Mean Height-Standard Deviation Score (SDS) at Months 12 and 18

Mean Growth Velocity-Standard Deviation Score (SDS) at Month 6

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

Change From Baseline in Height-Standard Deviation Score (SDS) at Month 6

Change From Baseline in Height-Standard Deviation Score (SDS) at Months 12 and 18

Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Month 6

Change From Baseline in Growth Velocity-Standard Deviation Score (SDS) at Months 12 and 18

Sitting Height-Standard Deviation Score (SDS)

Body Mass Index-Standard Deviation Score (BMI-SDS)

Change From Baseline in Head Circumference at Months 6, 12 and 18

Change From Baseline in Head Circumference-Standard Deviation Score (SDS) at Months 6, 12 and 18

Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Month 6

Change From Baseline in Skinfold Thickness-Standard Deviation Score (SDS) at Months 12 and 18

Minimum age: 6 Years. Maximum age: 10 Years. Gender(s): Both.

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.

Pfizer Investigational Site, Berlin 13353, Germany

Pfizer Investigational Site, Bonn 53113, Germany

Pfizer Investigational Site, Datteln 45711, Germany

Pfizer Investigational Site, Dresden 01307, Germany

Pfizer Investigational Site, Erlangen 91054, Germany

Pfizer Investigational Site, Essen 45122, Germany

Pfizer Investigational Site, Heidelberg 69120, Germany

Pfizer Investigational Site, Kiel 24105, Germany

Pfizer Investigational Site, Koeln 50937, Germany

Pfizer Investigational Site, Muenchen 80337, Germany

To obtain contact information for a study center near you, click here.

Starting date: July 2008
Last updated: January 27, 2012