Efficacy on Height in SGA Children Treated With Growth Hormone - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

November 13, 2008

Start Date ^†

November 2002

Current Primary Outcome Measures ^†

Evaluate effect on Height in SGA Children Treated with Growth Hormone [ Time Frame: After 2 years of treatment ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00184756 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Appetite
Height SDS, yearly

Original Secondary Outcome Measures ^†

Height SDS, yearly
Appetite

Descriptive Information

Brief Title ^†

Efficacy on Height in SGA Children Treated With Growth Hormone

Official Title ^†

Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.

Brief Summary

This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Small for Gestational Age (SGA)

Intervention ^†

Drug: somatropin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

180

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references.
Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion

Exclusion Criteria:

Growth Hormone Deficiency (GHD)
Treatment with any medical product which may interfere with GH effects
Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders

Gender

Both

Ages

5 Years to 8 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Czech Republic, Finland, Germany, Israel, Poland, Portugal, Spain, Sweden

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00184756

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Secondary IDs ^††

Study Sponsor ^†

Novo Nordisk

Collaborators ^††

Investigators ^†

Study Director:

Kirsten Jøns

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

November 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.