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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.
Sponsor:
Information provided by:
Centro Medico Teknon
ClinicalTrials.gov Identifier:
NCT00497562
First received: July 5, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  Purpose

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
Fibromyalgia
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497562

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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:
Fibromyalgia
growth hormone
IGF-1
FIQ

Additional relevant MeSH terms:
Dwarfism, Pituitary
Fibromyalgia
Myofascial Pain Syndromes
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Endocrine System Diseases
Hypopituitarism
Hypothalamic Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pituitary Diseases
Rheumatic Diseases
Amitriptyline
Amitriptyline, perphenazine drug combination
Fluoxetine
Hormones
Tramadol
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Antidepressive Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on November 20, 2014