NCT00156143

Brief Summary

To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2002

Typical duration for phase_3

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, 2002

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

July 30, 2007

Status Verified

July 1, 2007

First QC Date

September 7, 2005

Last Update Submit

July 27, 2007

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.

Interventions

Blood samplePROCEDURE
RadiographyPROCEDURE

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Males or females : Chronological age \> or = 15 years and \< or = 20 years for females
  • Chronological age \> or = 17 years and \< or = 20 years for males
  • GHD of childhood onset treated for at least 2 years
  • Last GH injection at least 12 months before baseline visit

You may not qualify if:

  • Turner's syndrome
  • Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT \> 2 X ULN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

April 1, 2002

Study Completion

April 1, 2005

Last Updated

July 30, 2007

Record last verified: 2007-07