Phase 3
N=98
Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
Foetal Growth Problem · Small for Gestational Age
Bottom Line
View on ClinicalTrials.gov: NCT00184717 ↗Enrolled (actual)
98
Serious AEs
32.5%
Results posted
Jul 2011
Primary outcome: Primary: Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years — -2.9488; -2.9047; 1.2066; 2.0247 Standard Deviation Score (SDS)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- somatropin (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Mar 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years |
-2.9488; -2.9047; 1.2066; 2.0247 | — |
| PRIMARY Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years |
-2.9603; -2.7481; 1.0997; 1.9151 | — |
| SECONDARY Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years |
-1.6299; -2.0303; 2.4717; 4.7875; 1.1344; 2.8877 | — |
| SECONDARY Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years |
0.073; -1.356; 2.1677; 5.9303; 1.5268; 3.3979 | — |
| SECONDARY Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years |
5.79; 7.15 | — |
| SECONDARY Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years |
6.54; 5.6 | — |
| SECONDARY Adverse Events - Subjects Received NN220 Treatment for 5 Years |
31; 34; 9; 16; 2; 4 | — |
| SECONDARY Adverse Events - Subjects Received NN220 Treatment for 4 Years |
7; 8; 1; 3; 0; 1 | — |
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 receive either active treatment for 104 weeks (two dosing regimens) or no treatment for 52 weeks followed by an extension period where subjects who received active treatment for 104 weeks (two years) will continue with the same treatment for further 156 weeks (three years) while those subjects who received no treatment for 52 weeks (one year) will be randomised to receive two dosing regimens for 208 weeks (four years). In total, subjects participate in trial for 260 weeks (five years).
Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension period is registered as GHLIQUID-1517.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Subjects with diabetes mellitus
- Subjects suffering from malignancy
- Several medical conditions
Data sourced from ClinicalTrials.gov (NCT00184717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.