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FibromyalgiaPhase 3NCT00933686

Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome

A Phase 3 study testing Saizen® in people with Fibromyalgia, run by Merck KGaA, Darmstadt, Germany at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fibromyalgia
What is being tested?
Saizen®
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
1 siteSpain
Study dates
Dec 2007to Jul 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Centro Medico Teknon, Endocrinology Department

    Barcelona

Other trials in Spain

About this study

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

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.

Conditions
Fibromyalgia
Being tested
Saizen®, Placebo and Saizen®
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saizen®Drug

    Also called Somatropin

    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.

  • 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.

Study groups in NCT00933686
Study groupRoleWhat they receive
Saizen®Active comparatorNot described
Receives: Drug: Saizen®
Placebo + Saizen®Active comparatorNot described
Receives: Drug: Placebo and Saizen®

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Month 6

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

    Measured: Month 12

Secondary outcomes (5)

  1. Fibromyalgia Impact Questionnaire (FIQ) Total Score

    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).

    Measured: Baseline, Month 1, 3, 6, 7, 9 and 12

  2. Visual Analog Scale (VAS) Total Score

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

    Measured: Baseline, Month 1, 3, 6, 7, 9 and 12

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

    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.

    Measured: Baseline, Month 1, 3, 6, 7, 9 and 12

  4. Multidimensional Assessment of Fatigue (MAF) Total Score

    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.

    Measured: Baseline, Month 6 and 12

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

    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.

    Measured: Baseline, Month 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2009 (estimated)
  2. Study startDec 2007
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00933686
Sponsor's protocol ID
27560
Status last verified
Aug 2013
First submitted
2 Jul 2009
Last updated
2 Aug 2013
Data monitoring committee
No

Publications

  • Cuatrecasas G, Alegre C, Fernandez-Sola J, Gonzalez MJ, Garcia-Fructuoso F, Poca-Dias V, Nadal A, Cuatrecasas G, Navarro F, Mera A, Lage M, Peino R, Casanueva F, Linan C, Sesmilo G, Coves MJ, Izquierdo JP, Alvarez I, Granados E, Puig-Domingo M. Growth hormone treatment for sustained pain reduction and improvement in quality of life in severe fibromyalgia. Pain. 2012 Jul;153(7):1382-1389. doi: 10.1016/j.pain.2012.02.012. Epub 2012 Mar 31.

    PubMed 22465047

  • Cuatrecasas 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.

    PubMed 20631018

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Saizen® in people with Fibromyalgia, run by Merck KGaA, Darmstadt, Germany at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Less Than 11 Tender Points at Month 6 (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00933686, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2013.

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