Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01734447
• Date of registration: 22/11/2012
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation
• Scientific title: Discontinued Administration (6 Months a Year) of Growth Hormone to Children With Very Short Stature and Having Suffered From Intrauterine Growth Retardation: Safety and Effect on Growth of Long-term Therapy
• Date of first enrolment: April 30, 2000
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01734447
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Foetal Growth Problem

Small for Gestational Age

Intervention(s)

Drug: somatropin

Primary Outcome(s)

Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion

Secondary Outcome(s)

Height velocity

Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray

Number of Adverse Events

Final height

Pubertal development, assessed according to Tanner method

Secondary ID(s)

GHRETARD/F/2/F

Source(s) of Monetary Support

Please refer to primary and secondary sponsors