Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome

Phase 3

Completed

Conditions: Fibromyalgia

Interventions: Drug: Saizen®
Drug: Placebo and Saizen®

Registration Number: NCT00933686

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 113

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saizen®	Saizen®	-
Placebo + Saizen®	Placebo and Saizen®	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Less Than 11 Tender Points at Month 6	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.
Percentage of Participants With Less Than 11 Tender Points at Month 12	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 Outcome Measures

Name	Time	Method
Fibromyalgia Impact Questionnaire (FIQ) Total Score	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).
Visual Analog Scale (VAS) Total Score	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.
EuroQol 5-Dimensions (EQ-5D) Total Score	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.
Multidimensional Assessment of Fatigue (MAF) Total Score	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.
Percentage of Participants With Positive Response on Quality of Life Assessment of Growth Hormone [GH] Deficiency in Adults (QoL AGHDA) Scale	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.