Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation

Condition(s) targeted: Growth Disorders; Intrauterine Growth Retardation

Intervention: Genotonorm (Drug); Genotonorm (Drug); Genotonorm (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

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

To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation

Official title: A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation

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

Primary outcome: Change From Baseline in Annual Growth Rate Measured at 2 Years Following Treatment With Genotonorm

Secondary outcome:

Annual Growth Rate Standard Deviation Score (SDS)

Change From Baseline in Annual Growth Rate SDS

Height (cm)

Change From Baseline in Height (cm)

Height (SDS)

Change From Baseline in Height (SDS)

Body Mass Index (BMI)

Weight

Change From Baseline in Bone Age

Change From Baseline in Bone Age/Change From Baseline in Chronological Age Ratio

Chronological Age at Onset of Puberty

Number of Subjects Reaching Puberty

Minimum age: 3 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Chronological age (CA) between 3 and 10 for girls

- Chronological age between 3 and 12 for boys

- Height for CA below - 2 SD

- Birth length for CA below -2SD

Exclusion Criteria:

- Endocrine disease except well-substituted hypothyroidism

- Sever chronic disease

- Skeletal dysplasia

- Known chromosomal aberration

- Ongoing treatment with steroids

- Known intrauterine infection

Pfizer Investigational Site, Amiens 80030, France

Pfizer Investigational Site, Angers cedex 49933, France

Pfizer Investigational Site, Besancon Cedex 25030, France

Pfizer Investigational Site, Bordeaux Cedex 33076, France

Pfizer Investigational Site, Bordeaux 33000, France

Pfizer Investigational Site, Boulogne 92100, France

Pfizer Investigational Site, Brest 29200, France

Pfizer Investigational Site, Bron Cedex 69677, France

Pfizer Investigational Site, Clermont Ferrand 63000, France

Pfizer Investigational Site, Dijon 21034, France

Pfizer Investigational Site, Grenoble 38043, France

Pfizer Investigational Site, Hyères 83407, France

Pfizer Investigational Site, Lille 59000, France

Pfizer Investigational Site, Lille 59037, France

Pfizer Investigational Site, Marseille cedex 5 13385, France

Pfizer Investigational Site, Montpellier 34059, France

Pfizer Investigational Site, Nantes Cedex 1 44093, France

Pfizer Investigational Site, Nice 06202, France

Pfizer Investigational Site, Paris 75571, France

Pfizer Investigational Site, Paris 75019, France

Pfizer Investigational Site, Paris 75674, France

Pfizer Investigational Site, Reims 51092, France

Pfizer Investigational Site, Rennes 35033, France

Pfizer Investigational Site, Rouen 76000, France

Pfizer Investigational Site, Saint Priest en Jarez 42277, France

Pfizer Investigational Site, Strasbourg Cedex 2 67098, France

Pfizer Investigational Site, Tarbes, France

Pfizer Investigational Site, Toulouse Cedex 31026, France

Pfizer Investigational Site, Tours 37044, France

Pfizer Investigational Site, Vandoeuvre Les Nancy Cedex 54511, France

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

Starting date: July 1993
Last updated: November 8, 2010