Status:
COMPLETED
Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Foetal Growth Problem
Small for Gestational Age
Eligibility:
All Genders
3-8 years
Phase:
PHASE3
Brief Summary
This study is conducted in Japan. The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age (SGA) in Japan. In the main period, subjects will...
Eligibility Criteria
Inclusion
- For MAIN period (GHLIQUID-1516):
- Born small for gestational age (SGA) with birth weight and birth length below the 10th percentile for gestational age, and additional either birth length below or equal to -2.0 standard deviation score (SDS) or birth weight below or equal to -2.0 SDS for gestational age
- Growth failure with height at -2.0 SDS or below for chronological age (CA)
- Normal growth hormone (GH) production, defined as peak GH level \> 10 ng/mL in one GH provocation test
- For EXTENSION period (GHLIQUID-1517):
- Subjects who completed the main period
- Chronological age (CA) for boys at least 4 years, but maximum 11 years
- Chronological age (CA) for girls at least 4 years, but maximum 10 years
Exclusion
- Subjects with diabetes mellitus
- Subjects suffering from malignancy
- Several medical conditions
Key Trial Info
Start Date :
August 18 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2009
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00184717
Start Date
August 18 2004
End Date
December 28 2009
Last Update
July 7 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005