Effect of Growth Hormone in Children With Growth Hormone Deficiency

Phase 3 Completed 173 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.

Timeline

Start: 2000-08
Primary completion: 2004-05
Completion: 2004-05

Outcome

Met primary endpoint

paper IGF((high)) showing significantly greater linear growth response (P < 0.001, compared with the other two groups). PMID 17356043 ↗

Publications

Results Cohen P, Rogol AD, Howard CP, Bright GM, Kappelgaard AM, Rosenfeld RG; American Norditropin Study Group. Insulin growth factor-based dosing of growth hormone therapy in children: a randomized, controlled study. J Clin Endocrinol Metab. 2007 Jul;92(7):2480-6. doi: 10.1210/jc.2007-0204. Epub 2007 Mar 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Somatropin	Protein / enzyme biologic	40 ug/kg	—