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Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia

This study has been completed.
Sponsor:
Collaborator:
Merck, S.L., Spain
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00933686
First received: July 2, 2009
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
 Drug: Somatropin
Drug: Placebo and Somatropin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Growth Hormone Treatment of Severe Fibromyalgia Syndrome Associated With Functional Failure of Somatotropic Axis. A Multicentre, Randomized, Double-blind, Placebo-controlled Study.

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Percentage of participants with less than 11 tender points at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Percentage of participants with less than 11 tender points at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fibromyalgia Impact Questionnaire (FIQ) Total Score [ Time Frame: Baseline, Months 1,3,6,7,9 and 12 ] [ Designated as safety issue: No ]
  • Visual Analog Scale (VAS) Total Score [ Time Frame: Baseline, Months 1,3,6,7,9 and 12 ] [ Designated as safety issue: No ]
  • Euro Quality of Life (EQ-5D) Total Score [ Time Frame: Baseline, Months 1,3,6,7,9 and 12 ] [ Designated as safety issue: No ]
  • Multidimensional Assessment of Fatigue (MAF) Total Score [ Time Frame: Baseline, Months 6 and 12 ] [ Designated as safety issue: No ]
  • Percentage of participants with response on Quality of Life Assessment of GH Deficiency in Adults (QoL AGHDA) scale [ Time Frame: Baseline, Months 6 and 12 ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: December 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Somatropin
Somatropin (Saizen) 0.006 milligram/kilogram (mg/kg), subcutaneously (s.c.) daily for 12 months
Placebo Comparator: 2 Drug: Placebo and Somatropin
Placebo for 6 months and Somatropin (Saizen) 0.006 mg/kg, s.c. daily for the next 6 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women > 18 years old
  • Fibromyalgia diagnosed at least one year ago
  • At least 16 positive tender points
  • Body Mass Index (B.M.I) < 35
  • Triple therapy (amitryptiline, tramadol and selective serotonin reuptake inhibitors [SSRI])
  • Active rehabilitation program during the previous year (at least 30 minutes/day)
  • Fibromyalgia Impact Questionnaire (FIQ) score > 75
  • Growth axis dysfunction: Normal Growth Hormone (GH) and low Insulin-like growth factor (IGF)- 1 levels
  • IGF-I serum level < 150 nanogram/milliliter (ng/mL)
  • Chronic Fatigue Syndrome
  • Postmenopausal or active contraceptive method
  • Written Informed consent

Exclusion Criteria:

  • Major psychiatric disorders
  • Rheumatic disease, including systemic lupus erythematosus (SLE)
  • Active or inactive neoplasia
  • Previous or current malignancies
  • History or suspicion of intracranial space occupying lesion
  • Reactive fibromyalgia syndrome or any chronic articular disease
  • Antinuclear antibody (ANA) > 1:80 (local Lab)
  • Abnormal Creatine phosphokinase (CPK) or aldolase serum levels (local Lab)
  • Uncontrolled thyroid disease (free Thyroxine [T4] and Thyrotrophin-stimulating hormone [TSH]) in the last 3 months
  • Uncontrolled diabetes mellitus
  • Adrenal gland disease (if abnormal low cortisolemia, 34-hours-cortisoluria)
  • Pregnancy or breast feeding
  • Known hypersensitivity to somatotropin or any of the excipients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933686

Locations
Spain
Centro Medico Teknon, Endocrinology Department
Barcelona, Spain
Sponsors and Collaborators
Merck KGaA
Merck, S.L., Spain
Investigators
Principal Investigator: Guillem Cuatrecasas, MD Centro Medico Teknon
  More Information

No publications provided by Merck KGaA

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00933686     History of Changes
Other Study ID Numbers: 27560
Study First Received: July 2, 2009
Last Updated: December 12, 2011
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013