Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Saizen®; Placebo and Saizen®
Intervention description: Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) will be administered subcutaneously daily for 12 months. Dose will be titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) is less than 50 percent of the baseline value. Dose titrations will be made at Month 1, 3, 7 and 9.; Placebo matched to Saizen® will be administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose will be titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) is less than 50 percent of the baseline value. Dose titrations will be made at Month 7 and 9.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 113.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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