Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome
Status and phase
Completed
Phase 3
Conditions
Fibromyalgia
Treatments
Drug: Saizen®
Drug: Placebo and Saizen®
Details and patient eligibility
About
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.
Enrollment
113 patients
Sex
Female
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
113 participants in 2 patient groups
Saizen®
Active Comparator group
Treatment:
Drug: Saizen®
Placebo + Saizen®
Active Comparator group
Treatment:
Drug: Placebo and Saizen®
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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