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

February 27, 2017 updated by: Novo Nordisk A/S

Evaluation of Efficacy and Safety of Somatropin in SGA Children Due to IUGR

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: somatropin

Study Type

Interventional

Enrollment (Actual)

160

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - Albacete, Spain, 02006
    - Novo Nordisk Investigational Site
  - Alicante, Spain, 03010
    - Novo Nordisk Investigational Site
  - Almería, Spain, 04009
    - Novo Nordisk Investigational Site
  - Badajoz, Spain, 06080
    - Novo Nordisk Investigational Site
  - Badalona, Spain, 08916
    - Novo Nordisk Investigational Site
  - Barcelona, Spain, 08025
    - Novo Nordisk Investigational Site
  - Barcelona, Spain, 08009
    - Novo Nordisk Investigational Site
  - Calella de la Costa, Spain, 08370
    - Novo Nordisk Investigational Site
  - Cáceres, Spain, 10002
    - Novo Nordisk Investigational Site
  - Córdoba, Spain, 14004
    - Novo Nordisk Investigational Site
  - El Palmar, Spain, 30120
    - Novo Nordisk Investigational Site
  - Elche, Spain, 3203
    - Novo Nordisk Investigational Site
  - Esplugues Llobregat, Spain, 08950
    - Novo Nordisk Investigational Site
  - Getafe, Spain, 28905
    - Novo Nordisk Investigational Site
  - Granada, Spain, 18012
    - Novo Nordisk Investigational Site
  - Granollers, Spain, 08400
    - Novo Nordisk Investigational Site
  - Huelva, Spain, 21005
    - Novo Nordisk Investigational Site
  - Jaén, Spain, 23007
    - Novo Nordisk Investigational Site
  - Las Palmas, Spain, 35016
    - Novo Nordisk Investigational Site
  - Leganés, Spain, 28911
    - Novo Nordisk Investigational Site
  - Madrid, Spain, 28009
    - Novo Nordisk Investigational Site
  - Madrid, Spain, 28046
    - Novo Nordisk Investigational Site
  - Madrid, Spain, 28007
    - Novo Nordisk Investigational Site
  - Madrid, Spain, 28041
    - Novo Nordisk Investigational Site
  - Martorell, Spain, 08760
    - Novo Nordisk Investigational Site
  - Mataró, Spain, 08304
    - Novo Nordisk Investigational Site
  - Málaga, Spain, 29011
    - Novo Nordisk Investigational Site
  - Palma de Mallorca, Spain, 07014
    - Novo Nordisk Investigational Site
  - Pamplona, Spain, 31008
    - Novo Nordisk Investigational Site
  - Sabadell, Spain, 08208
    - Novo Nordisk Investigational Site
  - Salamanca, Spain, 37007
    - Novo Nordisk Investigational Site
  - Santa Cruz de Tenerife, Spain, 38010
    - Novo Nordisk Investigational Site
  - Santander, Spain, 39008
    - Novo Nordisk Investigational Site
  - Sevilla, Spain, 41014
    - Novo Nordisk Investigational Site
  - Tarrasa, Spain, 08227
    - Novo Nordisk Investigational Site
  - Vitoria, Spain, 01009
    - Novo Nordisk Investigational Site
  - Zaragoza, Spain, 50009
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10
Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study
Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age
Normal response to GH stimulation test (greater than 10 ng/mL)

Exclusion Criteria:

Diabetes
Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders)
Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects
History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy
Previous or ongoing growth hormone therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Height gain according to birth group, age of onset, the treatment and Tanner stage Time Frame: during 12 months of treatment	during 12 months of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Height SDS for bone age Time Frame: during 12 months of treatment	during 12 months of treatment
Height velocity SDS for bone age Time Frame: during 12 months of treatment	during 12 months of treatment
Height velocity for chronological age Time Frame: during 12 months of treatment	during 12 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2003

Primary Completion (Actual)

June 29, 2005

Study Completion (Actual)