Phase 3 N=46 Treatment

Growth Retardation In Children With Special Pathological Conditions Or Disease

Endocrine System Diseases

Bottom Line

View on ClinicalTrials.gov: NCT00163215 ↗

Enrolled (actual)

Serious AEs

8.7%

Results posted

Dec 2012

Primary outcome: Primary: Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population — -1.29; 2.36 SDS

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Somatropin (Drug)
Age: Pediatric · 11+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Intent-to-Treat (ITT) Population	-1.29; 2.36	—
PRIMARY Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36 in Per-Protocol (PP) Population	-1.98; 2.70	—
SECONDARY Change From Baseline in Annual Growth Rate at Month 12, Month 24 and Month 36 in ITT Population	4.5; 3.3; 2.5; 2.0	—
SECONDARY Change From Baseline in Annual Growth Rate at Month 12, Month 24, Month 36 in PP Population	4.0; 4.0; 2.5; 1.8	—
SECONDARY Height	123.9; 130.3; 137.8; 143.5	—
SECONDARY Change From Baseline in Height at Month 12, Month 24 and Month 36	7.7; 14.9; 22.3	—
SECONDARY Mean Height Standard Deviation Score (SDS) for Chronological Age (CA)	-2.84; -2.42; -2.09; -1.72	—
SECONDARY Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, Month 24 and Month 36	0.41; 0.81; 1.03	—
SECONDARY Mean Height Standard Deviation Score (SDS) for Bone Age (BA)	-0.71; -0.55; -0.49; -0.30	—
SECONDARY Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, Month 24 and Month 36	-0.05; 0.06; 0.05	—
SECONDARY Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in ITT Population	3.23; 2.62	—
SECONDARY Change From Baseline in Annual Growth Rate Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12 and Month 24 in PP Population	4.40; 2.97	—
SECONDARY Mean Growth Rate Standard Deviation Score (SDS) for Bone Age (BA)	1.06; 0.46; -0.01	—
SECONDARY Body Mass Index (BMI)	16.57; 16.96; 17.59; 17.67	—
SECONDARY Change From Baseline in Body Mass Index (BMI) at Month 12, Month 24 and Month 36	0.52; 1.30; 1.89	—
SECONDARY Change From Baseline in Bone Age (BA) at Month 12, Month 24 and Month 36	8.70; 1.69; 2.60; 4.04	—
SECONDARY Ratio of Bone Age (BA) to Chronological Age (CA)	0.79; 0.83; 0.85; 0.89	—

Summary

To show an increase in annual growth rate 3 years after Visit 2. Annual growth rate in standard deviation (SD) after 3 years will be compared to growth rate before the start of GH treatment.

Eligibility Criteria

Inclusion Criteria

Bone age < 13 years for a boy and < 11 years for a girl
Naive child: Measured Height < -2.5 SD for CA
Child currently treated by GH

Exclusion Criteria

Idiopathic short stature
Syndrome known to be associated with an increased risk of cancer e.g. family history of adenomatous polyposis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00163215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.