NCT00452491

Brief Summary

  1. 1.To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens
  2. 2.To specify the best period of treatment
  3. 3.To assess the efficacy of treatment based on final adult height of these children

Trial Health

87
On Track

Trial Health Score

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

Enrollment
306

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 1993

Longer than P75 for phase_3

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

May 1, 1993

Completed
13.9 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 5, 2010

Status Verified

October 1, 2010

Enrollment Period

16.9 years

First QC Date

March 23, 2007

Last Update Submit

October 4, 2010

Conditions

Fetal Growth Retardation

Outcome Measures

Primary Outcomes (1)

  • Efficacy data : measurement of height

    at trimestrial visit

Secondary Outcomes (3)

  • laboratory test assessment and evaluation of bone age

    at every other visit

  • measurement of anti-GH and anti-ECP antibodies

    one visit out of four

  • Tolerance data : undesirable events

    throughout the study

Study Arms (2)

1

EXPERIMENTAL
Drug: somatropin

2

ACTIVE COMPARATOR
Drug: somatropin

Interventions

somatropinDRUG

0.2 IU/kg/day 7 days per week given sequentially (alternating periods of 6 months of treatment and 6 months of no treatment) for 3 years

1

Eligibility Criteria

Age3 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (I.U.G.R.)
  • Height Less Than or Equal to -3 SD

You may not qualify if:

  • Age less than 3 years
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Marie SEBILLE, Dr

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 23, 2007

First Posted

March 27, 2007

Study Start

May 1, 1993

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 5, 2010

Record last verified: 2010-10

Locations

FR(1)