Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2003-04-30

Brief Summary

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This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.

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Detailed Description

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Conditions

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Foetal Growth Problem Small for Gestational Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1.2, continuous treatment

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months

1.2, non-continuous treatment

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)

2.4, non-continuous treatment

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)

Interventions

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somatropin

1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months

Intervention Type DRUG

somatropin

1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)

Intervention Type DRUG

somatropin

2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)

Intervention Type DRUG