Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck, S.L., Spain
• Treatments: Hormones

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