NCT00145457

Brief Summary

To assess the predictive value of the short term IGF-1 stimulation test, based on IGF-1 changes, on the 24 months growth response to 2 different doses of GH in patients with conventional GH deficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_4

Geographic Reach
1 country

8 active sites

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 1, 2001

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

June 6, 2007

Status Verified

May 1, 2007

First QC Date

September 1, 2005

Last Update Submit

June 5, 2007

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

  • Change of height standard deviation score after 24 months of treatment according to the short term response of plasma IGF1 to Genotonorm.

Interventions

Blood samplePROCEDURE
RadiographyPROCEDURE

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female aged of more than 4 years.

You may not qualify if:

  • Previous treatment with GH
  • Ongoing pharmacological treatment with steroids except if corresponding to substitutive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Pfizer Investigational Site

Besançon, 25030, France

Location

Pfizer Investigational Site

Bordeaux, 33000, France

Location

Pfizer Investigational Site

Dunkirk, 59385, France

Location

Pfizer Investigational Site

Limoges, 87042, France

Location

Pfizer Investigational Site

Nice, 06202, France

Location

Pfizer Investigational Site

Paris, 75674, France

Location

Pfizer Investigational Site

Tarbes, 65013, France

Location

Pfizer Investigational Site

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Blood Specimen CollectionX-Rays

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

April 1, 2001

Study Completion

January 1, 2005

Last Updated

June 6, 2007

Record last verified: 2007-05

Locations

FR(8)