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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group)
• Drug: amitriptyline, fluoxetine and tramadol alone (control group)

Primary Measures

• reduction number of tender points (paired)
  • Time Frame: one year treatment
    

Secondary Measures

• improvement in FIQ, EQ-5D , analogic visual scales (1). Safety (2).
  • Time Frame: one year
    

Inclusion Criteria:

• Women greater than 18 years old with severe fibromyalgia and abnormally low IGF-1 levels included in a rehabilitation and psychological program and stable under standard intensive treatment for at least 6 months.
• All patients fulfilled the 1990 ACR diagnostic criteria (1) and had an IGF-1 level
• <250 ng/mL (or 1 standard deviation bellow the mean value corresponding to age and body surface according to laboratory reference value).
• Other inclusion criteria were duration of fibromyalgia of 1 year or greater, pain in at least 16 (8 bilateral) of the 18 tender points and a score in the FIQ > 75.
• The study was conducted in accordance with the Declaration of Helsinki and received the local institutional review board and Spanish Drug Agency (nº03-0456) approvals.
• All patients gave written informed consent prior to their inclusion in the study.

Exclusion Criteria:

• Disabling physical or mental status
• Previous or current malignancies, either active or inactive
• Intracranial space occupying lesion
• Any relevant endocrine disorder including diabetes mellitus
• History of another pituitary disorder
• Previous treatment with growth hormone
• Other systemic or joint inflammatory rheumatic conditions; and
• Known to be hypersensitive to somatropin or any of the excipients.
• Pregnant women, nursing mothers, or women with childbearing potential not using adequate contraceptive methods were also excluded.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Centro Medico Teknon

Overall Clinical Trial Officials and Contacts

Guillem Cuatrecasas, MD Principal Investigator CM Teknon Endocrinology Head Department  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00497562

Study ID Number: FibTek-0301

ClinicalTrials.gov Identifier: NCT00497562

Health Authority: Spain: Agencia Española del Medicamento y productos sanitarios