Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Small for Gestational Age; Foetal Growth Problem

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01734447

GHRETARD/F/2/F

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients born with IUGR enrolled in trial GHRETARD/F/1/F
• Bone age below 14 years in boys and 12 years in girls

Exclusion criteria

• Bone age above 14 years in boys and 12 years in girls

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 3 patient groups

1.2, continuous treatment

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin

Drug: somatropin

1.2, non-continuous treatment

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin

Drug: somatropin

2.4, non-continuous treatment

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin

Drug: somatropin