Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933686
• Other study ID #: 27560
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2009
• Last updated: August 1, 2013
• Start date: December 2007
• Est. completion date: July 2010

Study information

• Verified date: August 2013
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Saizen®
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®
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.

Locations

Country	Name	City	State
Spain	Centro Medico Teknon, Endocrinology Department	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck, S.L., Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 6	No
Primary	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.	Month 12	No
Secondary	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).	Baseline, Month 1, 3, 6, 7, 9 and 12	No
Secondary	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.	Baseline, Month 1, 3, 6, 7, 9 and 12	No
Secondary	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.	Baseline, Month 1, 3, 6, 7, 9 and 12	No
Secondary	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.	Baseline, Month 6 and 12	No
Secondary	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.	Baseline, Month 6 and 12	No