Subjects Allocated to no Treatment in Trial GHLIQUID-1516 Will Subsequently Receive Growth Hormone for 4 Years

Condition(s) targeted: Fetal Growth Retardation

Intervention: somatropin (Drug); somatropin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Yoshihisa Ogawa, Study Director, Affiliation: Novo Nordisk Pharma Ltd.

This Study is conducted in Japan.

This protocol describes an extension trial of GHLIQUID-1516 (GHLIQUID-1517) where subjects after two years of active treatment will continue with the same treatment for further 3 years in this trial and subjects allocated to no treatment group for one year in GHLIQUID-1516 will be randomised to two dosing regiments for 4 years in this trial.

Official title: Investigation of the Efficacy and Safety of Human Growth Hormone in Subjects With Short Stature Born Small for Gestational Age

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change in height SDS for chronological age

Secondary outcome:

Change in height velocity SDS for chronological age

Adverse events

Change in bone age (left hand X-Ray)

Minimum age: 4 Years. Maximum age: 10 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects who completed GHLIQUID-1516

Exclusion Criteria:

- Subject with diabetes mellitus

- Subject suffering from malignancy

- Several medical conditions

Asahikawa city, Japan

Clinical Trials at Novo Nordisk

Starting date: August 2004
Ending date: March 2010
Last updated: February 13, 2008