NCT00497562

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

Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Centro Medico Teknon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia
• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group)
DRUG	amitriptyline, fluoxetine and tramadol alone (control group)

Timeline

• Start date: 2004-05-01
• Completion: 2005-11-01
• First posted: 2007-07-06
• Last updated: 2007-07-06

Locations

1 site across 1 country: Spain