Growth Hormone Treatment in Children Born Small for Gestational Age - Full Text View

Sponsor:	Novo Nordisk
Information provided by (Responsible Party):	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00184717

Purpose

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.

Condition	Intervention	Phase
Foetal Growth Problem Small for Gestational Age (SGA)	Drug: somatropin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	GHLIQUID-1516: A 104-week, Multi-centre, Randomised, Double-blind, Parallel-group, no Treatment Controlled (Open-label) Trial Investigating the Efficacy and Safety of Two Doses of NN-220 in Subjects With Short Stature Born Small for Gestational Age / GHLIQUID-1517: A Long-term, Multi-centre, Randomised, Controlled, Double-blind, Parallel-group Trial, Investigating the Efficacy and Safety of Two Doses of NN-220 in Subjects With Short Stature Born Small for Gestational Age

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

MedlinePlus related topics: Dwarfism

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 Outcome Measures:

Yearly Height Velocity SDS for Chronological Age - Subjects Received NN220 Treatment for 5 Years [ Time Frame: Weeks 0-260 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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

Enrollment:	98
Study Start Date:	July 2003
Study Completion Date:	December 2009
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Drug: somatropin 0.033 mg/kg/day of NN-220 for s.c. injection in cartridge
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	Drug: somatropin 0.067 mg/kg/day of NN-220 for s.c. injection in cartridge
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	Drug: somatropin 0.033 mg/kg/day of NN-220 for s.c. injection in cartridge
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	Drug: somatropin 0.067 mg/kg/day of NN-220 for s.c. injection in cartridge

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184717

Locations

Japan

Tokyo, Japan, 103

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Yoshihisa Ogawa

Novo Nordisk Pharma Ltd.

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00184717 History of Changes
Obsolete Identifiers:	NCT00184704
Other Study ID Numbers:	GHLIQUID-1516, GHLIQUID-1517, JapicCTI-050137, JapicCTI-050132
Study First Received:	September 13, 2005
Results First Received:	December 22, 2010
Last Updated:	January 24, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on February 09, 2012