Skip to main content
OpenTrials
Completed

NCT Number: NCT00933686

Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centro Medico Teknon, Endocrinology Department

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saizen®

Drug

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 names: Somatropin

Placebo and Saizen®

Drug

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.

Primary outcomes

  1. Percentage of Participants With Less Than 11 Tender Points at Month 6

    Time frame: Month 6

    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.

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

    Time frame: Month 12

    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 outcomes

  1. Fibromyalgia Impact Questionnaire (FIQ) Total Score

    Time frame: Baseline, Month 1, 3, 6, 7, 9 and 12

    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).

  2. Visual Analog Scale (VAS) Total Score

    Time frame: Baseline, Month 1, 3, 6, 7, 9 and 12

    Visual Analog Scale (VAS) is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain.

  3. EuroQol 5-Dimensions (EQ-5D) Total Score

    Time frame: Baseline, Month 1, 3, 6, 7, 9 and 12

    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.

  4. Multidimensional Assessment of Fatigue (MAF) Total Score

    Time frame: Baseline, Month 6 and 12

    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.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck, S.L., Spain

Registry information

Official study title

Growth Hormone Treatment of Severe Fibromyalgia Syndrome Associated With Functional Failure of Somatotropic Axis. A Multicentre, Randomized, Double-blind, Placebo-controlled Study.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 7, 2009
Registry last updated
Aug 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.