Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age - Full Text View

Sponsor:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00249821

Purpose

Multicentric pilot comparative study, open-label, randomised, in parallel groups comparing one group of patients receiving 0.057mg/kg/day (0.40mg/kg/week) of Saizen® during 1 year to one group receiving 0.035mg/kg/day (0.24mg/kg/week) of Saizen® during 1 year after a 3-year treatment of r-hGH therapy with 0.057mg/kg/day in both groups

Condition	Intervention	Phase
Small for Gestational Age	Drug: Saizen	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:	Optimization of the Dosage Regimen With Growth Hormone Therapy in Children Born Small for Gestational Age. An Open Label, Randomized, Pilot Study, Comparing in Children Treated for 3 Years, the Efficacy of a Saizen® Treatment at the Same Dose Versus a Lower Maintenance Dose Prolonged During 1 Additional Year.

Resource links provided by NLM:

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by EMD Serono:

Primary Outcome Measures:

The efficacy will be assessed by the height gain expressed in cm/year and SDS/year during the fourth year. [ Time Frame: 4th year ]

Secondary Outcome Measures:

Height velocity-Standard deviation Score, height and Height-S standard deviation Score. Local tolerance at the injection site, clinical tolerance and biological tolerance by assessing fasting glycemia, insulinemia, and Ultrasensitive TSH [ Time Frame: Clinical Tolerance every 6 mos., biological tolerance after 1 yr. treatment ]

Estimated Enrollment:	100
Study Start Date:	February 2005
Estimated Study Completion Date:	September 2007

Eligibility

Ages Eligible for Study:	6 Years to 11 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

To be eligible for inclusion / randomisation into this study, the subjects must fulfil all of the following criteria (if there is no inclusion phase, the inclusion criteria will be considered as inclusion criteria for randomisation).

Written consent form signed by the parents / legal guardian, and child if possible.
Patient born SGA and receiving a r-hGH therapy for this pathology.
r-hGH started at the maximal chronological age of 7 years for girls and 8 years for boys.
Treatment with r-hGH started for at least 30 months and less than 36 months at 0.057mg/kg/d
Height gain during the first 2 years of GH treatment >1SD compared with the initial value.

Exclusion Criteria:

To be eligible for inclusion in this study the subjects must not meet any of the following criteria:

Known hypersensitivity to Somatropin or any of the excipients.
Active neoplasia (either newly diagnosed or recurrent).
Intracranial hypertension
Known diabetes mellitus
Proliferative or preproliferative diabetic retinopathy
Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion
Obesity defined as degree 1 on the corpulence curves
Precocious puberty
Pubertal status: Tanner breast development stage >2 for girls, and testicular volume >4ml or testicular length >3cm and/or testosterone value >1nmol/l (0.29g/ml) for boys.

For girls >9 years and Tanner breast development stage 1: uterine size > 35mm

Severe chronic concomitant illness such as chronic renal failure, cystic fibrosis
Concomitant corticoid treatment or levothyroxine treatment other than substitutive treatment, topical or inhaled treatment
Participation to any clinical study within the 30 days preceding study entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249821

Locations

France
Local Medical Information Office
Paris, France

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Dominique ROGER, M.D.

Sponsor GmbH

More Information

Additional Information:

Full FDA approved prescribing information can be found here This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	25735, SGA OPTIMIS
Study First Received:	November 4, 2005
Last Updated:	March 21, 2009
ClinicalTrials.gov Identifier:	NCT00249821 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority; France: Institutional Ethical Committee

ClinicalTrials.gov processed this record on February 04, 2010