Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome

PHASE3CompletedINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
Fibromyalgia
Interventions
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.

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.

Trial Locations (1)

Unknown

Centro Medico Teknon, Endocrinology Department, Barcelona

All Listed Sponsors
collaborator

Merck, S.L., Spain

INDUSTRY

lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

NCT00933686 - Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome | Biotech Hunter | Biotech Hunter