Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome

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: August 1, 2013
Last verified: August 2013
  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: Saizen®
Drug: Placebo and Saizen®
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:


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 ]
    The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the American College of Rheumatology (ACR) criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.

  • Percentage of Participants With Less Than 11 Tender Points at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    The musculoskeletal component in form of pain on palpation in at least 11 of 18 tender point sites is required to fulfill the ACR criteria for fibromyalgia syndrome, An important response is considered when the number of tender points falls below 11 since it is the threshold for fibromyalgia diagnosis.


Secondary Outcome Measures:
  • Fibromyalgia Impact Questionnaire (FIQ) Total Score [ Time Frame: Baseline, Month 1, 3, 6, 7, 9 and 12 ] [ Designated as safety issue: No ]
    Fibromyalgia Impact Questionnaire (FIQ) is a 10-item questionnaire that measures physical impairment, well-being, missed work, pain, fatigue, rest, stiffness, anxiety, and depression. Score ranges from 0 (best result - very well) to 100 (worst result - awful).

  • Visual Analog Scale (VAS) Total Score [ Time Frame: Baseline, Month 1, 3, 6, 7, 9 and 12 ] [ Designated as safety issue: No ]
    Visual Analog Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain.

  • EuroQol 5-Dimensions (EQ-5D) Total Score [ Time Frame: Baseline, Month 1, 3, 6, 7, 9 and 12 ] [ Designated as safety issue: No ]
    EuroQol 5-Dimensions (EQ-5D) questionnaire is a measure of health status and quality of life (QoL). The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Score range for each item is 0 to 3, with 3 being the most severe. Total score range is 0 to 15. Lower scores represent a better QoL.

  • Multidimensional Assessment of Fatigue (MAF) Total Score [ Time Frame: Baseline, Month 6 and 12 ] [ Designated as safety issue: No ]
    Multidimensional Assessment of Fatigue (MAF) consists of 16 questions. The score range for first 14 questions is between 0 and 10 for each question while for the last two questions it is 0 and 4 for each question. Total score range for first 14 questions is 0 to 100 and for last two questions is 0 to 8. Lower scores on the each represent the better participant's condition, whereas, higher scores indicate worsening condition.

  • Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale [ Time Frame: Baseline, Month 6 and 12 ] [ Designated as safety issue: No ]
    Quality of Life Assessment of GH Deficiency in Adults (QoL AGHDA) questionnaire consists of 25 items that evoke yes or no answers. A score of 1 is given to each item affirmed and these are summed to give the total score. The maximum score is 25, which represents a poor quality of life. The minimum score is 0, which represents a good quality of life. Each question has to be answered with a NO/YES and for each YES, one point is added. The more YES, the higher the score and the worse. Decrease in the positive responses is an index of improvement. So, when the percentage of positive responses on the scale decreases, it is considered a response rate.


Enrollment: 113
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: Saizen® Drug: Saizen®
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.
Other Name: Somatropin
Active Comparator: Placebo + Saizen® Drug: Placebo and Saizen®
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: April 15, 2013
Last Updated: August 1, 2013
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 August 25, 2014