Sponsor study identifier
Secondary identifiers
interventional
N/A
1 country
1
Study Start
May 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
November 2005
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2005
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2004
Date type not reportedThis date has not been verified as actual or estimated.
November 2005
Actual (reported)July 5, 2007
Actual (reported)July 6, 2007
Actual (reported)reduction number of tender points (paired)
one year treatment
improvement in FIQ, EQ-5D , analogic visual scales (1). Safety (2).
one year
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Grouped treatment entry
sc recombinant growth hormone + amitriptyline, fluoxetine and tramadol (treated group)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
amitriptyline, fluoxetine and tramadol alone (control group)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordEndocrinology Department CM Teknon
Barcelona, Barcelona, 08022, Spain
Bennett RM, Clark SC, Walczyk J. A randomized, double-blind, placebo-controlled study of growth hormone in the treatment of fibromyalgia. Am J Med. 1998 Mar;104(3):227-31. doi: 10.1016/s0002-9343(97)00351-3.
Leal-Cerro A, Povedano J, Astorga R, Gonzalez M, Silva H, Garcia-Pesquera F, Casanueva FF, Dieguez C. The growth hormone (GH)-releasing hormone-GH-insulin-like growth factor-1 axis in patients with fibromyalgia syndrome. J Clin Endocrinol Metab. 1999 Sep;84(9):3378-81. doi: 10.1210/jcem.84.9.5982.
Guillem Cuatrecasas, MD
CM Teknon Endocrinology Head Department
Albert Nadal, MD
CM Teknon Rheumatology Head Department
First Submitted
July 5, 2007
First Posted
July 6, 2007
Study Start
May 2004
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
November 2005
Actual (reported)Mild Water-Filtered Near Infrared Whole-Body-Hyperthermia as an Adjunct in the Treatment of Fibromyalgia
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Cuatrecasas G, Riudavets C, Guell MA, Nadal A. Growth hormone as concomitant treatment in severe fibromyalgia associated with low IGF-1 serum levels. A pilot study. BMC Musculoskelet Disord. 2007 Nov 30;8:119. doi: 10.1186/1471-2474-8-119.
Last Updated
July 6, 2007
Record last verified: 2007-07
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Source: ClinicalTrials.gov.
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