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

July 5, 2007
July 5, 2007
May 2004
Not Provided
reduction number of tender points (paired) [ Time Frame: one year treatment ]
Same as current
No Changes Posted
improvement in FIQ, EQ-5D , analogic visual scales (1). Safety (2). [ Time Frame: one year ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Fibromyalgia
  • Growth Hormone Deficiency
  • Drug: sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group)
  • Drug: amitriptyline, fluoxetine and tramadol alone (control group)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
November 2005
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00497562
FibTek-0301, 03-0453 (AGEMED)
Yes
Not Provided
Centro Medico Teknon
Not Provided
Principal Investigator: Guillem Cuatrecasas, MD CM Teknon Endocrinology Head Department
Study Chair: Albert Nadal, MD CM Teknon Rheumatology Head Department
Centro Medico Teknon
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP