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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: Saizen® (Drug); Placebo and Saizen® (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 6

Percentage of Participants With Less Than 11 Tender Points at Month 12

Secondary outcome:

Fibromyalgia Impact Questionnaire (FIQ) Total Score

Visual 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

Page last updated: August 23, 2015

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