NCT00519844

Brief Summary

This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

6 months

First QC Date

August 22, 2007

Last Update Submit

November 11, 2015

Conditions

Foetal Growth ProblemSmall for Gestational Age

Outcome Measures

Primary Outcomes (1)

  • Satisfaction/preference with the method of treatment assesses by means of a satisfaction questionnaire and a standard questionnaire of preference

    after 3 months of treatment

Secondary Outcomes (4)

  • Clinical (adverse events)

  • Biological (fasting glucose, fasting insulin, liver enzymes)

  • Tolerance of the treatment

  • Compliance

Interventions

somatropinDRUG

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children treated for 3 years with Maxomat® because of small for gestational age
  • Postnatal growth failure by the age of 3 years or more
  • No associated growth hormone deficiency
  • Bone age no more than 13 years for girls and no more than 15 years for boys

You may not qualify if:

  • Known, evolving tumour
  • Hypertrophic cardiomyopathy
  • Hypertension not controlled on maximum therapy
  • Benign intracranial hypertension
  • Known glucose intolerance or known diabetes mellitus
  • Acute or active chronic hepatitis
  • Chronic renal failure
  • Chromosomal and/or genetic syndromes (other than Silver-Russell syndrome) or abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Lyon, 69000, France

Location

Related Links

MeSH Terms

Interventions

Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 23, 2007

Study Start

July 1, 2005

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

FR(1)