Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Apr 1999

Longer than P75 for phase_3

Geographic Reach

1 country

13 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

6.2 years study duration

Study Start

First participant enrolled

April 1, 1999

Completed

6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed

Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

6.2 years

First QC Date

September 13, 2005

Last Update Submit

January 17, 2017

Conditions

Foetal Growth Problem Small for Gestational Age

Outcome Measures

Primary Outcomes (2)

Effect on Efficacy: Height SDS for chronological age
after 48 months
Safety: Bone maturation and glucose metabolism

Secondary Outcomes (1)

Efficacy: Height SDS for bone age; Height velocity SDS for bone age; Height velocity SDS for chronological age; Serum IGF-I and IGFBP-3 levels

Interventions

somatropinDRUG

Eligibility Criteria

Age2 Years - 5 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

IUGR defined as birth length and/or weight below the lower limit (\< P10) of the Lubchenco curves for the gestational age.
Chronological age = 2-5 years
HV below average for CA
Insufficient catch-up growth (Height \< P3 for chronological age, according to Hernández)
Parental height greater than or equal to -2 SDS of average, that is, 160 cm or more for the father and 148 cm or more for the mother
Normal response to GH stimulation test (greater tan or equal to 10 ng/mL)
Bone age (measured through Greulich and Pyle method) less than or equal to CA

You may not qualify if:

Children born from multiple pregnancy
Children with post-ischemic encephalopathy
Recorded malformative syndromes associated to short stature (Silver-Russell, Rubinstein Taybi, Seckel etc.)
Any metabolic or endocrinological disorder (diabetes mellitus, diabetes insipidus, congenital metabolic disorders, with the exception of thyroid diseases corrected by replacement therapy)
Any type of growth retardation associated to infections, embryopathies or severe chronic diseases (hemopathies, hepatopathies, malabsorptive pathology, neurologic alterations....)
Nutritional disorders (celiac disease) or osteodystrophies
Patients who receive or received any treatment (anabolic drugs, sex steroids, etc.) likely to interfere with GH effects
Abnormal karyotype
Neoplasms
Previous or ongoing chemotherapy and/or irradiation
Renal dysfunction, defined as serum creatinine \> 1 mg/dL

Contact the study team to confirm eligibility.