NCT01734447

Brief Summary

This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2000

Typical duration 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

April 30, 2000

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2003

Completed
9.6 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

3 years

First QC Date

November 22, 2012

Last Update Submit

February 27, 2017

Conditions

Foetal Growth ProblemSmall for Gestational Age

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion

Secondary Outcomes (5)

  • Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray

  • Pubertal development, assessed according to Tanner method

  • Height velocity

  • Final height

  • Number of Adverse Events

Study Arms (3)

1.2, continuous treatment

EXPERIMENTAL
Drug: somatropin

1.2, non-continuous treatment

EXPERIMENTAL
Drug: somatropin

2.4, non-continuous treatment

EXPERIMENTAL
Drug: somatropin

Interventions

somatropinDRUG

1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months

1.2, continuous treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients born with IUGR enrolled in trial GHRETARD/F/1/F
  • Bone age below 14 years in boys and 12 years in girls

You may not qualify if:

  • Bone age above 14 years in boys and 12 years in girls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Paris, 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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2012

First Posted

November 27, 2012

Study Start

April 30, 2000

Primary Completion

April 30, 2003

Study Completion

April 30, 2003

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

FR(1)