NCT00174421

Brief Summary

This trial evaluates whether long-term treatment with Genotropin normalizes final (adult) height in short children born small for gestational age

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2001

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, 2001

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

May 3, 2007

Status Verified

May 1, 2007

First QC Date

September 12, 2005

Last Update Submit

May 1, 2007

Conditions

Growth Disorder

Outcome Measures

Primary Outcomes (1)

  • Final height, compared to the expected familial target height

Secondary Outcomes (1)

  • Body weight, body mass index at final height; adverse events and assessment of hematological and clinical chemistry

Interventions

Treatment with Genotropin in different dosagesDRUG

Eligibility Criteria

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

You may qualify if:

  • Participation in the 90-080 study

You may not qualify if:

  • Any severe, acute or chronic disease
  • Any other identifiable reason for short stature

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Growth Disorders

Interventions

TherapeuticsHuman Growth Hormone

Condition Hierarchy (Ancestors)

Pathologic 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

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

April 1, 2001

Study Completion

August 1, 2005

Last Updated

May 3, 2007

Record last verified: 2007-05