Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height

Growth Disorder Clinical Trial

Official title:

Genotropin in Short Children Born Small for Gestational Ag - A Long-Term Study in Belgium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174421
• Other study ID #: 98-8122-011
• Secondary ID: A6281219
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 1, 2007
• Start date: April 2001
• Est. completion date: August 2005

Study information

• Verified date: May 2007
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participation in the 90-080 study

Exclusion Criteria:

• Any severe, acute or chronic disease

• Any other identifiable reason for short stature

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Growth Disorder
• Growth Disorders

Intervention

Drug:
• Treatment with Genotropin in different dosages

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final height, compared to the expected familial target height
Secondary	Body weight, body mass index at final height; adverse events and assessment of hematological and clinical chemistry