Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-18

Study Completion Date

2009-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing

NCT01110928

Foetal Growth Problem Small for Gestational Age

COMPLETED

Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

NCT01734447

Foetal Growth Problem Small for Gestational Age

COMPLETED PHASE4

Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction

NCT00519844

Foetal Growth Problem Small for Gestational Age

COMPLETED PHASE4

Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age

NCT00557336

Foetal Growth Problem Small for Gestational Age

COMPLETED PHASE3

Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age

NCT00174460

Growth Hormone Therapy Infant, Very Low Birth Weight

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Foetal Growth Problem Small for Gestational Age

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

0.033 mg / NN-220

In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

0.033 mg/kg/day of NN-220 for s.c. injection in cartridge

0.067 mg / NN-220

In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

0.067 mg/kg/day of NN-220 for s.c. injection in cartridge

No treatment

No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period

Group Type NO_INTERVENTION

No interventions assigned to this group

No treatment --> 0.033 mg

In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

0.033 mg/kg/day of NN-220 for s.c. injection in cartridge

No treatment --> 0.067 mg

In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

0.067 mg/kg/day of NN-220 for s.c. injection in cartridge

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

somatropin

0.033 mg/kg/day of NN-220 for s.c. injection in cartridge

Intervention Type DRUG

somatropin

0.067 mg/kg/day of NN-220 for s.c. injection in cartridge

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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