Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00184717Other idGHLIQUID-1517Other idJapicCTI-050137Other idJapicCTI-050132Other id2017-000914-47

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 98 participants (actual)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Double masking
Countries: 1 country
Japan
Start: 18 Aug 2004
Primary completion: 29 Mar 2006
Completion: 28 Dec 2009
First posted: 16 Sept 2005 (estimated)
Last update posted: 7 Jul 2017
Conditions: Foetal Growth Problem · Small for Gestational Age

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2004200520062007200820092010

Ph 3
Growth Hormone Treatment in Children Born Small for Gestational Age (SGA)
NCT00184717
18 Aug 2004 to 28 Dec 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

somatropinDrug
somatropinDrug

Arms5

Experimental
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
Experimental
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
No intervention
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
Experimental
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
Experimental
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

Primary outcomes2

Outcomes the sponsor listed as primary.

Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years
Time frame · Week 0, week 260
Registry description
Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit
Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years
Time frame · Week 0, week 208
Registry description
Height SDS for chronological age were derived as follow; {Height - mean (age, sex)}/ SD (age, sex), where mean (age, sex) and SD (age, sex) were mean and SD of height for corresponding chronological age and sex (data of those in 2000). Height SDS was calculated using mean of three height observations at corresponding visit

Secondary outcomes(6)

Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years
Time frame · Weeks 0-260
Registry description
Yearly Height velocity SDS for chronological age were summarised and graphically presented
Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years
Time frame · Weeks 0-208
Registry description
Yearly Height velocity SDS for chronological age were summarised and graphically presented
Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years
Time frame · Week 0, week 260
Registry description
Bone age is measured as years and months (displayed as xx.x years). Change in Bone age = Bone age at 52\*i weeks - Bone age at 52\*(i-1) weeks, i=1, 2, ….
Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years
Time frame · Week 0, week 208
Registry description
Bone age is measured as years and months (displayed as xx.x years).Change in Bone age = Bone age at 52\*i weeks - Bone age at 52\*(i-1) weeks, i=1, 2, ….
Adverse Events - Subjects Received NN220 Treatment for 5 Years
Time frame · Weeks 0-260
Registry description
Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly
Adverse Events - Subjects Received NN220 Treatment for 4 Years
Time frame · Weeks 0-208
Registry description
Occurrence of Adverse Events (AEs) during treatment period (TEAEs), occurrence of possibly/probably related AEs during the treatment period, and occurrence of Serious Adverse Events (SAEs) during the treatment period. An AE is any undesirable medical event occurring to a subject in a clinical trial, whether or not related to the trial product(s). An SAE is an experience that at any dose is fatal, life-threatening, disabling or which results in the patient being hospitalised or, if already in hospital, that hospitalisation is prolonged, or ocurrence of congenital anomaly

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Week 0, week 260

Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 260 - Subjects Received NN220 Treatment for 5 Years

Group	Value (Standard Deviation Score (SDS))	Spread
0.033 mg / NN-220	-2.9488	0.6368
0.067 mg / NN-220	-2.9047	0.6718
No Treatment --> 0.033 mg	not posted	–
No Treatment --> 0.067 mg	not posted	–

Primary outcomeLeast squares mean· Week 0, week 208

Change in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Week 208 - Subjects Received NN220 Treatment for 4 Years

Group	Value (Standard Deviation Score (SDS))	Spread
0.033 mg / NN-220	not posted	–
0.067 mg / NN-220	not posted	–
No Treatment --> 0.033 mg	-2.9603	0.6689
No Treatment --> 0.067 mg	-2.7481	0.3524

Secondary and other outcome results(6)

Secondary outcomeMean· Weeks 0-260

Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years

Group	Value (Standard Deviation Score (SDS))	Spread
0.033 mg / NN-220	-1.6299	0.9738
0.067 mg / NN-220	-2.0303	1.4527
No Treatment --> 0.033 mg	not posted	–
No Treatment --> 0.067 mg	not posted	–

Secondary outcomeMean· Weeks 0-208

Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 4 Years

Group	Value (Standard Deviation Score (SDS))	Spread
0.033 mg / NN-220	not posted	–
0.067 mg / NN-220	not posted	–
No Treatment --> 0.033 mg	0.073	1.5681
No Treatment --> 0.067 mg	-1.356	0.708

Secondary outcomeMean· Week 0, week 260

Change in Bone Age (Left Hand X-Ray) at Week 260 - Subjects Received NN220 Treatment for 5 Years

Group	Value (years)	Spread
0.033 mg / NN-220	5.79	1.05
0.067 mg / NN-220	7.15	1.05
No Treatment --> 0.033 mg	not posted	–
No Treatment --> 0.067 mg	not posted	–

Secondary outcomeMean· Week 0, week 208

Change in Bone Age (Left Hand X-Ray) at Week 208 - Subjects Received NN220 Treatment for 4 Years

Group	Value (years)	Spread
0.033 mg / NN-220	not posted	–
0.067 mg / NN-220	not posted	–
No Treatment --> 0.033 mg	6.54	1.26
No Treatment --> 0.067 mg	5.6	1.68

Secondary outcomeNumber· Weeks 0-260

Adverse Events - Subjects Received NN220 Treatment for 5 Years

Group	Value (Subjects)
0.033 mg / NN-220	31
0.067 mg / NN-220	34
No Treatment --> 0.033 mg	not posted
No Treatment --> 0.067 mg	not posted

Secondary outcomeNumber· Weeks 0-208

Adverse Events - Subjects Received NN220 Treatment for 4 Years

Group	Value (Subjects)
0.033 mg / NN-220	not posted
0.067 mg / NN-220	not posted
No Treatment --> 0.033 mg	7
No Treatment --> 0.067 mg	8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
0.033 mg / NN-220	–	12 / 31	31 / 31
0.067 mg / NN-220	–	11 / 34	34 / 34
0.033 mg / No Treatment	–	1 / 7	7 / 7
0.067 mg / No Treatment	–	2 / 8	8 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

PubMed tag: none · 2016

The influence of a long-term growth hormone treatment on lipid and glucose metabolism: a randomized trial in short Japanese children born small for gestational age.

Horikawa et al. 2016International journal of pediatric endocrinologycited by 12

PMID 27799945PMC5080766DOI 10.1186/s13633-016-0036-4PUB-27799945

CC BY

Download PDF

Indexing hint: Randomized controlled trial · 2014

The impact of long-term growth hormone treatment on metabolic parameters in Japanese patients with short stature born small for gestational age.

Kappelgaard et al. 2014Hormone research in paediatricscited by 20

PMID 24526136DOI 10.1159/000358196PUB-24526136

Full text at the publisher

Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultTanaka T, Yokoya S, Seino Y, Togari H, Mishina J, Kappelgaard AM, Fujieda K. Long-term efficacy and safety of two doses of growth hormone in short Japanese children born small for gestational age. Horm Res Paediatr. 2011;76(6):411-8. doi: 10.1159/000334152. Epub 2011 Nov 29. PMID 22156542

Eligibility

Who could join, as posted.

Sex: All
Age: from 3 Years up to 8 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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