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

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00184717

Purpose

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.

Condition	Intervention	Phase
Fetal Growth Retardation	Drug: somatropin	Phase III

Drug Information available for: Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Investigation of the Efficacy and Safety of Human Growth Hormone in Subjects With Short Stature Born Small for Gestational Age

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Change in height SDS for chronological age [ Time Frame: From baseline to the end of treatment (208 weeks or 260 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in height velocity SDS for chronological age [ Time Frame: from baseline to the end of treatment (208 weeks or 260 weeks) ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: during 208 weeks or 260 weeks of treatment ] [ Designated as safety issue: Yes ]
Change in bone age (left hand X-Ray) [ Time Frame: from baseline to the end of treatment (208 weeks or 260 weeks) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	89
Study Start Date:	August 2004
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: somatropin 0.033 mg/kg/day for s.c. injection in cartridge for 208 weeks (control patients) to 260 weeks.
B: Active Comparator	Drug: somatropin 0.067 mg/kg/day for s.c. injection in cartridge for 208 weeks (control patients) to 260 weeks.

Eligibility

Ages Eligible for Study:	4 Years to 10 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who completed GHLIQUID-1516

Exclusion Criteria:

Subject with diabetes mellitus
Subject suffering from malignancy
Several medical conditions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184717

Locations

Japan

Asahikawa city, Japan

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Yoshihisa Ogawa

Novo Nordisk Pharma Ltd.

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	GHLIQUID-1517, JAPIC: JapicCTI-050132
Study First Received:	September 13, 2005
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00184717
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Fetal Diseases
Pregnancy Complications
Growth Disorders
Fetal Growth Retardation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009