NEUROMUSCULAR CHANGES IN SMALL FOR GESTATIONAL AGE (SGA-) CHILDREN DURING SOMATROPIN THERAPY - A PROSPECTIVE, RANDOMIZED, CONTROLLED, OPEN-LABEL, MULTICENTER TRIAL (SGA-POWER STUDY) - SGA-Power study

• Register: EUCTR
• Last refreshed on: 11 March 2013
• Main ID: EUCTR2006-004304-39-DE
• Date of registration: 12/12/2007
• Prospective Registration: Yes
• Primary sponsor: Pfizer Pharma GmbH
• Public title: NEUROMUSCULAR CHANGES IN SMALL FOR GESTATIONAL AGE (SGA-) CHILDREN DURING SOMATROPIN THERAPY - A PROSPECTIVE, RANDOMIZED, CONTROLLED, OPEN-LABEL, MULTICENTER TRIAL (SGA-POWER STUDY) - SGA-Power study
• Scientific title: NEUROMUSCULAR CHANGES IN SMALL FOR GESTATIONAL AGE (SGA-) CHILDREN DURING SOMATROPIN THERAPY - A PROSPECTIVE, RANDOMIZED, CONTROLLED, OPEN-LABEL, MULTICENTER TRIAL (SGA-POWER STUDY) - SGA-Power study
• Date of first enrolment: 12/03/2008
• Target sample size: 88
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-004304-39
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: treated vs untreated group during 6 month study period

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
1. Pre-pubertal boys between 6 and 10 years of age or girls between 6 and 9 years of age
2. 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)
3. Current height-SDS < -2.5 (Brandt/Reinken 1992) and parental adjusted height-SDS < -1 (Hermanussen and Cole 2003)
4. Growth velocity SDS < 0 during the last year before inclusion (Brandt/Reinken 1988)
5. Girls: Tanner stage 1 breast development (Tanner 1962)
6. Boys: Testis volume = 3 ml (Prader 1966)
7. Tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on growth velocity, insulin sensitivity and body composition)
8. Evidence of a personally signed and dated informed consent document indicating that both parents of the subject (both legally acceptable representatives) has been informed of all pertinent aspects of the study and oral/written consent of subject due to age specific information has been obtained
9. Subject (and a legally acceptable representative) is willing to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Severe SGA (birth weight or length < -4 SD) and clinically relevant dysmorphic features
2. Severe pre-maturity (GA < 32 weeks of gestation)
3. 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)
4. Inability to perform one- or two leg jumps from a standing position
5. Prior GH treatment
6. Other endocrine diseases except for well substituted hypothyroidism (stable replacement therapy for at least 3 months prior to randomization)
7. Any severe acute or chronic diseases (neurological, respiratory, gastrointestinal etc) or medication that might influence linear growth, cognitive performance or insulin sensitivity (e.g. prednisolone for more than 7 days in doses above 10 mg per day or other per oral glucocorticosteroids in equivalent doses are not permitted throughout the trial. Treatment with topical or inhaled steroids is permitted). Individuals should not be under treatment of musculoskeletal diseases. Moreover, the administration of neuropharmacological and psychopharmacological drugs is not allowed (including methylphenidate, atomoxetin)
8. Known diabetes mellitus
9. Active malignancy/tumor or history of malignancy/tumor disease
10. Turner syndrome in girls
11. Other defined chromosomal aberrations or syndromes (e.g. fetal alcohol syndrome, osteochondrodysplasia), except Silver-Russell syndrome
12. Suspected non-compliance or impossibility to follow the treatment schedule, respectively (e.g. social implications)
13. Defined neurological defects, e.g. paresis, severe microcephaly
14. Severe non-corrected impaired vision
15. Ongoing psychotherapy
16. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
17. Participation in any other study during active treatment phase
18. Any other contraindications and warnings referring to the SGA indication and referenced in the actual local SmPC version of Genotropin®



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS < 0 during the last year) by 4 years of age or later.
MedDRA version: 9.1 Level: LLT Classification code 10041093 Term: Small for gestational age

Intervention(s)

Trade Name: Genotropin 5 mg/ml
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Somatropin
CAS Number: 12629-01-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Trade Name: Genotropin 12 mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Somatropin
CAS Number: 12629-01-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 12-

Primary Outcome(s)

Secondary Objective: Secondary objectives are to determine positive effects of growth hormone on cognitive performance (especially attention, alertness and memory), motor performance and coordinative skills as defined by peak jump power, peak jump force and maximal jump velocity, increment in muscle strength (dynamometer), changes in body composition (skinfold thickness measurements), changes in height SDS and growth velocity SDS. Furthermore, it should be demonstrated that growth hormone therapy in SGA children is safe and no new or unexpected side effects compared to the classical indications are probable.

Main Objective: Primary objective is to determine whether growth hormone therapy improves motor- performance and coordinative skills in pre-pubertal individuals with SGA as defined by efficiency of muscular function.

Primary end point(s): • Changes in efficiency of muscular function (Emf) after six months (two-leg-jump; Leonardo jump plate)(hierarchic testing)

Secondary ID(s)

N/A

A6281283