Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome
Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibromyalgia
Intervention: SaizenĀ® (Drug); Placebo and SaizenĀ® (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck KGaA Official(s) and/or principal investigator(s): Guillem Cuatrecasas, MD, Principal Investigator, Affiliation: Centro Medico Teknon
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Less Than 11 Tender Points at Month 6Percentage of Participants With Less Than 11 Tender Points at Month 12
Secondary outcome: Fibromyalgia Impact Questionnaire (FIQ) Total ScoreVisual Analog Scale (VAS) Total Score EuroQol 5-Dimensions (EQ-5D) Total Score Multidimensional Assessment of Fatigue (MAF) Total Score Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Centro Medico Teknon, Endocrinology Department, Barcelona, Spain
Additional Information
Starting date: December 2007
Last updated: August 1, 2013
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