Phase 3
N=113
Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome
Fibromyalgia
Bottom Line
View on ClinicalTrials.gov: NCT00933686 ↗Enrolled (actual)
113
Serious AEs
3.5%
Results posted
Aug 2013
Primary outcome: Primary: Percentage of Participants With Less Than 11 Tender Points at Month 6 — 20; 22 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Saizen® (Drug); Placebo and Saizen® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Less Than 11 Tender Points at Month 6 |
20; 22 | — |
| PRIMARY Percentage of Participants With Less Than 11 Tender Points at Month 12 |
53; 34 | — |
| SECONDARY Fibromyalgia Impact Questionnaire (FIQ) Total Score |
85.7; 86.0; 74.6; 73.3; 72.1; 66.4 | — |
| SECONDARY Visual Analog Scale (VAS) Total Score |
73.3; 74.3; 65.1; 68.0; 63.7; 58.4 | — |
| SECONDARY EuroQol 5-Dimensions (EQ-5D) Total Score |
11.07; 11.24; 10.46; 10.45; 10.13; 10.06 | — |
| SECONDARY Multidimensional Assessment of Fatigue (MAF) Total Score |
90; 83; 85; 78; 73; 78 | — |
| SECONDARY Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale |
73; 72; 70; 69; 59; 70 | — |
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.
Eligibility 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(= = 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
Data sourced from ClinicalTrials.gov (NCT00933686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.