Status:
COMPLETED
Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck, S.L., Spain
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00933686
Start Date
December 1 2007
End Date
July 1 2010
Last Update
August 2 2013
Active Locations (1)
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1
Centro Medico Teknon, Endocrinology Department
Barcelona, Spain