Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome

NCT ID: NCT00933686

Last Updated: 2013-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Saizen®

Group Type: ACTIVE_COMPARATOR

Saizen®

Intervention Type: 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.

Placebo + Saizen®

Group Type: ACTIVE_COMPARATOR

Placebo and Saizen®

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Somatropin

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(=<) 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck, S.L., Spain

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillem Cuatrecasas, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Medico Teknon

Locations

Centro Medico Teknon, Endocrinology Department

Barcelona, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 22465047 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20631018 (View on PubMed)

Other Identifiers

27560

Identifier Type: -

Identifier Source: org_study_id