113
Participants
Start Date
December 31, 2007
Primary Completion Date
July 31, 2010
Study Completion Date
July 31, 2010
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.
Centro Medico Teknon, Endocrinology Department, Barcelona
Merck, S.L., Spain
INDUSTRY
Merck KGaA, Darmstadt, Germany
INDUSTRY