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

Sponsor:	Merck KGaA
Information provided by:	Merck KGaA
ClinicalTrials.gov Identifier:	NCT00249821

Purpose

Multicentric, open-label, randomized, pilot comparative study 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 recombinant human growth hormone (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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 Merck KGaA:

Primary Outcome Measures:

Height [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Absolute variation between Randomisation Visit and V3 at 12 month (V3-Randomisation Visit) expressed in cm/year

Enrollment:	22
Study Start Date:	February 2005
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Saizen 0.057mg/kg/day Subjects who met all inclusion/exclusion criteria were randomly assigned in a 1:1 ratio to one of the two dose regimens (0.057mg/kg/day, 0.035mg/kg/day) in this multi-center study. Subjects were stratified at randomisation according to the Height-Standard Deviation Scale (H-SDS) at this time (<-2 SDS or >- 2 SDS)	Drug: Saizen Saizen® [somatropin (rDNA origin) for injection], a recombinant human growth hormone, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. Other Name: somatropin
Experimental: Saizen 0.035mg/kg/day Subjects who met all inclusion/exclusion criteria were randomly assigned in a 1:1 ratio to one of the two dose regimens (0.057mg/kg/day, 0.035mg/kg/day) in this multi-center study. Subjects were stratified at randomisation according to the H-SDS at this time (<-2 SDS or >- 2 SDS)	Drug: Saizen Saizen® [somatropin (rDNA origin) for injection], a recombinant human growth hormone, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. Other Name: somatropin

Eligibility

Ages Eligible for Study:	6 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Sponsors and Collaborators

Merck KGaA

Investigators

Study Director:

Laurence Fresneau, M.D.

Merck Serono S.A.S., France, an affiliate of Merck KGaA, Darmstadt, Germany

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Laurence Fresneau, MD, Merck Serono s. a. s., France, an affiliate of Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier:	NCT00249821 History of Changes
Other Study ID Numbers:	25735
Study First Received:	November 4, 2005
Last Updated:	August 11, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority; France: Institutional Ethical Committee

Additional relevant MeSH terms:

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012