NCT03033121: GH 3 wk dose

Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children

Completed Phase 3 Last updated 27 October 2017

What this trial tests

Phase 3 trial testing Growth Hormone in Growth Hormone Treatment in 32 participants. Completed in 1 January 2017.

Timeline

1 January 2016

Primary endpoint
1 January 2017

1 January 2017

Quick facts

Lead sponsor	University of Palermo
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	1 January 2016
Primary completion	1 January 2017
Estimated completion	1 January 2017
Sites	1 location across Italy

Drugs / interventions tested

• Growth Hormone — full drug profile →

Conditions studied

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

Sponsor

University of Palermo

Who can join

Adults 6 to 12, any sex, with Growth Hormone Treatment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is often not complied. The auxological effect of three injections per week (TIW) regimen is controversial, while the metabolic effects were never evaluated in children. The objective of this study was to evaluate whether two different regimens of weekly injections could lead to similar auxological and metabolic effects in children with GHD.

Publications & conference data

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

1. More Favorable Metabolic Impact of Three-Times-Weekly versus Daily Growth Hormone Treatment in Naïve GH-Deficient Children.
   Ciresi A, Cicciò F, Radellini S, Guarnotta V, et al · · 2017 · cited 6× · PMID 28634491 · DOI 10.1155/2017/8469680