drugset / Trial / NCT00497562

Growth Hormone as Add-on Treatment in Severe Fibromyalgia With Low IGF-1 Serum Levels (56 Characters)

NCT00497562

Phase 2 Completed Centro Medico Teknon
RandomizedParallel-groupOpen-labelTreatment

Summary

There are evidences of functional growth hormone (GH) deficiency, expressed by means of low serum levels of insulin-like growth factor 1 (IGF-1), in a subset of fibromyalgia patients. The efficacy of low GH doses versus placebo has been demonstrated in this population. We assessed the efficacy and safety of GH added to standard therapy compared to standard therapy alone in the treatment of severe, prolonged and well-treated fibromialgya patients with low IGF-1 levels.

Timeline

Start
2004-05
Primary completion
Completion
2005-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Somatropin Protein / enzyme biologic 0.0125 mg/kg Subcutaneous
Background Amitriptyline Small molecule
Background Fluoxetine Small molecule
Background Tramadol Other / unclassified