Conditions: Fibromyalgia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 113
Healthy volunteers: no

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:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Saizen® intervention 2: Placebo and Saizen®
Intervention descriptions: intervention 1: 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 2: 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.

Protocol document: