Somatropin Therapy for Short Children Born of Premature Gestation: A Controlled, Prospective Randomized, Multicenter Study with an Untreated Control Group - N/A

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-004781-33-DE
• Date of registration: 25/05/2005
• Prospective Registration: Yes
• Primary sponsor: Pfizer Pharma GmbH
• Public title: Somatropin Therapy for Short Children Born of Premature Gestation: A Controlled, Prospective Randomized, Multicenter Study with an Untreated Control Group - N/A
• Scientific title: Somatropin Therapy for Short Children Born of Premature Gestation: A Controlled, Prospective Randomized, Multicenter Study with an Untreated Control Group - N/A
• Date of first enrolment: 13/07/2005
• Target sample size: 70
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004781-33
• 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: Untreated control group

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
1) Prepubertal caucasian boys between 4 and 10 years of age and girls between 4 and 9 years of age.
Girls: Tanner stage 1 breast development
Boys: Testis volume = 3 ml
Tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on growth velocity, insulin sensitivity and body composition).
(In case of any signs or symptoms of gonadal puberty a GnRH-test must decide if the subject is still prepubertal)

2) Height = -2 SD for chronological age (Brandt/Reinken).

3) Growth velocity SDS below 0 SD for chronological age (Brandt/Reinken based on 12 ± 3 months observation period before screening).

4) Premature born defined as = 1500 g birth weight.

5) GH sufficiency (GH level >7 µg/l following any routine GH stimulation test).

6) Written informed consent of both parents (legal guardians) and oral/written consent of patient due to age specific information.

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) Other endocrine diseases except for well substituted hypothyroidism.

2) Severe chronic diseases or medication that might influence linear growth or insulin sensitivity (e.g. Glucocorticoids).

3) Positive GAD (Glutamatdecarboxylase, GAD65) and IA-2 (Tyrosinphosphatase) antibodies (for type 1 diabetes).
(Note: A positive result of antibody determinations confirms type 1 diabetes but a negative result of GAD antibodies does not exclude type 1 diabetes).

4) History of malignancy.

5) Children who meet all of the following criteria:
· actual body height <-2,5 SDS (Brandt/Reinken) and parent adjusted target height < -1 SDS (Hermanussen + Cole)
· length and/or body weight retardations adjusted to gestational age at birth <-2,0 SDS (Lawrence et al., 1989, Voigt et al., 1996)
· children with chronological age =4 years and
· growth velocity < 0 SDS during the last year before inclusion.

6) Chromosomal aberrations or syndromes.

7) Suspected non-compliance or impossibility to follow the two or three year treatment schedule, respectively (e.g. social implications).

8) Severe hemiparesis and severe CNS defects.

9) Retinopathia = third degree or coagulation treatment.

10) Participation in any other clinical trial during active treatment phase.

11) Other severe acute or chronic medical or psychiatric condition or clinically relevant laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.



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

Health Condition(s) or Problem(s) studied

Short children born of premature gestation

Intervention(s)

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

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

Primary Outcome(s)

Secondary Objective: To determine improvement of growth velocity and height SDS after two years, changes in body composition (skinfold thickness measurements), changes in bone density, bone structure and bone stability (peripheral quantitative computed tomography (pQCT)), changes in muscle strength (grip force) as well as insulin sensitivity.

Main Objective: To determine whether growth hormone therapy improves growth velocity and height SDS after one year in (very low birth weight (VLBW) preterm infants born appropriate-for-gestational age (AGA) with short stature.

Primary end point(s): Changes in growth velocity SDS and height SDS after one year.

Secondary ID(s)

A6281273