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

NCT00497562 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2007-07-06

No results posted yet for this study

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

DRUG

sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group)

DRUG

amitriptyline, fluoxetine and tramadol alone (control group)

Sponsors & Collaborators

  • Centro Medico Teknon

    lead OTHER

Principal Investigators

  • Guillem Cuatrecasas, MD · CM Teknon Endocrinology Head Department

  • Albert Nadal, MD · CM Teknon Rheumatology Head Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Completion
2005-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00497562 on ClinicalTrials.gov