Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

Phase 3 Completed 112 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth Hormone Deficiency, comparing two different treatment regiments.

Timeline

Start: 2003-12-06
Primary completion: 2005-12-28
Completion: 2005-12-28

Publications

Chihara K, Kato Y, Shimatsu A, Tanaka T, Kohno H. Efficacy and safety of individualized growth hormone treatment in adult Japanese patients with growth hormone deficiency. Growth Horm IGF Res. 2008 Oct;18(5):394-403. doi: 10.1016/j.ghir.2008.02.002. Epub 2008 Apr 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Somatropin	Protein / enzyme biologic	0.012 mg/kg	—

Indications

No indication recorded.