NCT00163189

Evolution Of Growth Rate In Children With Growth Retardation Related To Long-term Corticotherapy And Treated By Genotonorm

Completed Phase 3 Results posted Last updated 19 February 2024

What this trial tests

Phase 3 trial testing Somatropin in Growth Hormone Deficiency in 98 participants. Completed in 1 December 2014.

Timeline

1 January 2005

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	98
Start date	1 January 2005
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	19 locations across France

Drugs / interventions tested

• Somatropin (Somatropin) — full drug profile →

Conditions studied

• Growth Hormone Deficiency — all drugs for Growth Hormone Deficiency →

Sponsor

Pfizer — full company profile →

Who can join

Eligibility, any sex, with Growth Hormone Deficiency. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population
  Time frame: Baseline, Month 36
  Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for heigh
• Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population
  Time frame: Baseline, Month 36
  Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for heigh

Sponsor's own description

To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and safety of recombinant growth hormone treatment in children with growth retardation related to long-term glucocorticosteroid therapy.
   Basmaison O, Ranchin B, Zouater H, Robertson A, et al · · 2019 · cited 3× · PMID 30910221 · DOI 10.1016/j.ando.2019.02.001