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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00174421

First received: September 12, 2005

Last updated: May 1, 2007

Last verified: May 2007

History of Changes

Purpose

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

Condition	Intervention	Phase
Growth Disorder	Drug: Treatment with Genotropin in different dosages	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Genotropin in Short Children Born Small for Gestational Ag - A Long-Term Study in Belgium

Resource links provided by NLM:

Genetics Home Reference related topics: Meier-Gorlin syndrome metatropic dysplasia pseudoachondroplasia

Drug Information available for: Somatropin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Final height, compared to the expected familial target height

Secondary Outcome Measures:

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


Estimated Enrollment:	36
Study Start Date:	April 2001
Estimated Study Completion Date:	August 2005

Eligibility


Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participation in the 90-080 study

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174421

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

No publications provided


ClinicalTrials.gov Identifier:	NCT00174421 History of Changes
Other Study ID Numbers:	98-8122-011, A6281219
Study First Received:	September 12, 2005
Last Updated:	May 1, 2007
Health Authority:	Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on March 03, 2015

To Top