Clinical trial NCT00933686: Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome
Official title: Growth Hormone Treatment of Severe Fibromyalgia Syndrome Associated With Functional Failure of Somatotropic Axis. A Multicentre, Randomized, Double-blind, Placebo-controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fibromyalgia
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck, S.L., Spain
First posted: 2009-07-07
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of recombinant human growth hormone (r-hGH) treatment in severe fibromyalgia subjects with growth axis dysfunction.


Eligibility criteria: Inclusion Criteria:

* Women aged greater than or equal (\>=) 18 years
* Fibromyalgia diagnosed at least one year before
* History of generalized pain and at least 16 positive tender points (1990 American College of Rheumatology \[ACR\] criteria)
* Body Mass Index (BMI) less than or equal to(=\<) 32
* Normal GH stimulation test (insulin)
* Stable (\>= 3 months unchanged) standard treatment with amitriptyline (10-50 milligram per day \[mg/day\]) plus selective serotonin reuptake inhibitor (10-40 mg/day) plus tramadol (25-400 mg/day)
* Active rehabilitation program during the previous year (at least 30 minutes/day)
* Fibromyalgia Impact Questionnaire (FIQ) score \>=75
* IGF-1 serum level =\< 150 nanogram/milliliter (ng/mL) otherwise =\< 2 SD of the local lab normality)
* Normal response to IGF-1 generation test
* Chronic Fatigue Symptoms (Multidimensional Assessment of Fatigue \[MAF\])
* Effective anti-conception
* Willingness to comply with the protocol
* Written Informed consent

Exclusion Criteria:

* Major psychiatric condition
* Rheumatic disease, including systemic lupus erythematosus (SLE)
* Previous or current malignancies, active or inactive
* Clinical history intracranial space occupying lesion
* Reactive or secondary (rheumatoid arthritis \[RA\], osteoarthritis) fibromyalgia syndrome (FMS)
* Antinuclear antibody (ANA) greater than or equal 1:80
* Abnormal Creatine phosphokinase (CPK) or aldolase serum levels
* Not controlled thyroid disease in the last 3 months (free Thyroxine \[T4\] and Thyrotrophin-stimulating hormone \[TSH\] serum levels)
* Diabetes mellitus
* Adrenal gland disease (any abnormal cortisolemia, will be confirmed by 24-hour cortisoluria)
* Pregnancy or breast feeding
* Known to be hypersensitive to somatotropin or any of the excipients

Primary outcomes:
measure: Percentage of Participants With Less Than 11 Tender Points at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Less Than 11 Tender Points at Month 12
timeFrame: Month 12
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ) Total Score
timeFrame: Baseline, Month 1, 3, 6, 7, 9 and 12
measure: Visual Analog Scale (VAS) Total Score
timeFrame: Baseline, Month 1, 3, 6, 7, 9 and 12
measure: EuroQol 5-Dimensions (EQ-5D) Total Score
timeFrame: Baseline, Month 1, 3, 6, 7, 9 and 12
measure: Multidimensional Assessment of Fatigue (MAF) Total Score
timeFrame: Baseline, Month 6 and 12
measure: Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale
timeFrame: Baseline, Month 6 and 12
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro Medico Teknon, Endocrinology Department
Study officials:
affiliation: Centro Medico Teknon
name: Guillem Cuatrecasas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cuatrecasas G, Alegre C, Fernandez-Sola J, Gonzalez MJ, Garcia-Fructuoso F, Poca-Dias V, Nadal A, Cuatrecasas G, Navarro F, Mera A, Lage M, Peino R, Casanueva F, Linan C, Sesmilo G, Coves MJ, Izquierdo JP, Alvarez I, Granados E, Puig-Domingo M. Growth hormone treatment for sustained pain reduction and improvement in quality of life in severe fibromyalgia. Pain. 2012 Jul;153(7):1382-1389. doi: 10.1016/j.pain.2012.02.012. Epub 2012 Mar 31.
citation: Cuatrecasas G, Gonzalez MJ, Alegre C, Sesmilo G, Fernandez-Sola J, Casanueva FF, Garcia-Fructuoso F, Poca-Dias V, Izquierdo JP, Puig-Domingo M. High prevalence of growth hormone deficiency in severe fibromyalgia syndromes. J Clin Endocrinol Metab. 2010 Sep;95(9):4331-7. doi: 10.1210/jc.2010-0061. Epub 2010 Jul 14.