Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome

NCT00933686 | Completed Phase 3 Results

• 1 other identifier: 27560
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• Fibromyalgia Impact Questionnaire (FIQ) Total Score

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

• Visual Analog Scale (VAS) Total Score

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

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

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

• Multidimensional Assessment of Fatigue (MAF) Total Score

  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

  Baseline, Month 6 and 12

Study Arms (2)

Saizen®

ACTIVE COMPARATOR

Drug: Saizen®

Placebo + Saizen®

ACTIVE COMPARATOR

Drug: Placebo and Saizen®

Interventions

Saizen® DRUG

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.

Also known as: Somatropin

Saizen®

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.

Placebo + Saizen®

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck, S.L., Spain: collaborator

Study Sites (1)

Centro Medico Teknon, Endocrinology Department

Barcelona, Spain

Location

Related Publications (2)

• 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.

  PMID: 22465047 DERIVED

• 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.

  PMID: 20631018 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merck.de

+49-6151-72-5200

Study Officials

• Guillem Cuatrecasas, MD

  Centro Medico Teknon

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 7, 2009
• Study Start: December 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 2, 2013
• Results First Posted: August 2, 2013

Record last verified: 2013-08

Locations

ES (1)