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

This study has been completed.
Information provided by:
Centro Medico Teknon Identifier:
First received: July 5, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
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.

Condition Intervention Phase
Growth Hormone Deficiency
Drug: sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group)
Drug: amitriptyline, fluoxetine and tramadol alone (control group)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploratory Study to Investigate the Efficacy and Safety of Recombinant Growth Hormone as Add-on Treatment in Patients With Severe Fibromialgia

Resource links provided by NLM:

Further study details as provided by Centro Medico Teknon:

Primary Outcome Measures:
  • reduction number of tender points (paired) [ Time Frame: one year treatment ]

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

Study Start Date: May 2004
Study Completion Date: November 2005

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00497562

Endocrinology Department CM Teknon
Barcelona, Spain, 08022
Sponsors and Collaborators
Centro Medico Teknon
Principal Investigator: Guillem Cuatrecasas, MD CM Teknon Endocrinology Head Department
Study Chair: Albert Nadal, MD CM Teknon Rheumatology Head Department
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00497562     History of Changes
Other Study ID Numbers: FibTek-0301  03-0453 (AGEMED) 
Study First Received: July 5, 2007
Last Updated: July 5, 2007
Health Authority: Spain: Agencia Española del Medicamento y productos sanitarios

Keywords provided by Centro Medico Teknon:
growth hormone

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Dwarfism, Pituitary
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Bone Diseases, Developmental
Bone Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Amitriptyline, perphenazine drug combination
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents processed this record on October 28, 2016