NCT00174408

Brief Summary

The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 1990

Longer than P75 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

March 1, 1990

Completed
14.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months 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 Disorders

Outcome Measures

Primary Outcomes (1)

  • Height, height velocity

Secondary Outcomes (1)

  • Side effects

Interventions

GenotropinDRUG

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth length below -2 SD
  • Height at start below - 2 Sd

You may not qualify if:

  • Any endocrine or chronic disease
  • Any known syndrome with short stature

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Growth Disorders

Interventions

Human 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
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

March 1, 1990

Study Completion

February 1, 2005

Last Updated

May 3, 2007

Record last verified: 2007-05