Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00625872

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 III

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:

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Changes in peak jump power (PJP), peak jump force (PJF) and maximal jump velocity (Vmax) after six months (two-leg-jump; Leonardo jump plate)(hierarchic testing) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intellectual performance test battery for assessment of neurocognitive function in children [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Changes in peak jump power (PJP), peak jump force (PJF) and maximal jump velocity (Vmax)(one-leg-jump; Leonardo jump plate) [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Improvement in chair rising test (one/five stand up test) [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Changes in maximal isometric grip force using hand grip dynamometer [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Changes in bone density, bone structure and bone stability using pqCT (in selected centers only, where pqCT belongs to clinical standard) [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Upper arm, thigh and calf circumferences [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Height (cm) and growth velocity (cm/yr) [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Height SDS and growth velocity SDS for chronological age [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Change of height SDS and growth velocity SDS for chronological age [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Sitting height SDS [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Body mass index (SDS) [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Change in head circumference (cm) [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Change in head circumference (SDS) [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Changes in body composition (skinfold thickness SDS) [ Time Frame: 6/12/18 months ] [ Designated as safety issue: No ]
Standard diagnostic procedures (blood samples) to control the safety of GH-therapy [ Time Frame: 6/12/18 months ] [ Designated as safety issue: Yes ]

Enrollment:	25
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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00625872 History of Changes
Other Study ID Numbers:	A6281283
Study First Received:	February 19, 2008
Last Updated:	March 31, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medicinal Devices (BfArM)

ClinicalTrials.gov processed this record on February 09, 2012