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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome

NCTNCT00933686 (opens ClinicalTrials.gov in a new tab)Other id27560
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
113 participants (actual)
Sponsor
Merck KGaA, Darmstadt, Germany · Industry
Design
Randomized · Double masking
Countries
1 country

Spain

Start
Dec 2007
Primary completion
Jul 2010
Completion
Jul 2010
First posted
7 Jul 2009 (estimated)
Last update posted
2 Aug 2013 (estimated)
Conditions
Fibromyalgia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20072008200920102011
  1. Ph 3

    Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome

    NCT00933686

    Dec 2007 to Jul 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Saizen®Drug
  • Placebo and Saizen®Drug

Arms2

  • Active comparator

    Saizen®

  • Active comparator

    Placebo + Saizen®

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · Month 6

    Registry description

    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

    Registry description

    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(5)

  1. Fibromyalgia Impact Questionnaire (FIQ) Total Score

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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Month 6

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

GroupValue (Percentage of participants)
Saizen®20
Placebo + Saizen®22
Primary outcomeNumber· Month 12

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

GroupValue (Percentage of participants)
Saizen®53
Placebo + Saizen®34
Secondary and other outcome results(5)
Secondary outcomeMean· Baseline, Month 1, 3, 6, 7, 9 and 12

Fibromyalgia Impact Questionnaire (FIQ) Total Score

GroupValue (Units on a scale)Spread
Saizen®85.72.3
Placebo + Saizen®86.01.8
Secondary outcomeMean· Baseline, Month 1, 3, 6, 7, 9 and 12

Visual Analog Scale (VAS) Total Score

GroupValue (mm)Spread
Saizen®73.33.4
Placebo + Saizen®74.33.1
Secondary outcomeMean· Baseline, Month 1, 3, 6, 7, 9 and 12

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

GroupValue (Units on a scale)Spread
Saizen®11.070.44
Placebo + Saizen®11.240.42
Secondary outcomeNumber· Baseline, Month 6 and 12

Multidimensional Assessment of Fatigue (MAF) Total Score

GroupValue (Units on a scale)
Saizen®90
Placebo + Saizen®83
Secondary outcomeNumber· Baseline, Month 6 and 12

Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale

GroupValue (Percentage of participants)
Saizen®73
Placebo + Saizen®72

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Saizen®Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.–4 / 5545 / 55
Placebo + Saizen®Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.–0 / 5851 / 58

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2012

Growth hormone treatment for sustained pain reduction and improvement in quality of life in severe fibromyalgia.

Cuatrecasas et al. 2012Paincited by 33

PMID 22465047DOI 10.1016/j.pain.2012.02.012PUB-22465047

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedCuatrecasas G, Gonzalez MJ, Alegre C, Sesmilo G, Fernandez-Sola J, Casanueva FF, Garcia-Fructuoso F, Poca-Dias V, Izquierdo JP, Puig-Domingo M. High prevalence of growth hormone deficiency in severe fibromyalgia syndromes. J Clin Endocrinol Metab. 2010 Sep;95(9):4331-7. doi: 10.1210/jc.2010-0061. Epub 2010 Jul 14. PMID 20631018

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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