Growth Hormone Treatment in Children Born Small for Gestational Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184717
First received: September 13, 2005
Last updated: March 22, 2012
Last verified: March 2012
  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
Drug: somatropin
Phase 3

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:


Further study details as provided by Novo Nordisk A/S:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Yoshihisa Ogawa Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
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: March 22, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on July 24, 2014