Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency

PHASE3CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

June 30, 2006

Study Completion Date

July 31, 2006

Conditions
Childhood-onset Growth Hormone DeficiencyPituitary Dwarfism
Interventions
BIOLOGICAL

recombinant human growth hormone

0.005 mg/kg/day for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.

BIOLOGICAL

recombinant human growth hormone

0.010 mg/kg/day for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.

Trial Locations (9)

10032

Columbia University, New York

14222

Women's and Children's Hospital of Buffalo, Buffalo

15213

Children's Hospital of Pittsburgh, Pittsburgh

30342

Pediatric Endocrine Associates, Atlanta

32226

Nemours Children's Clinic, Jacksonville

32308

Pediatric Endocrinology Children's Clinic, Tallahassee

32806

Nemours Children's Clinic, Orlando

53226

Children's Hospital of Wisconsin, Milwaukee

92868

Children's Hospital of Orange County, Orange

Sponsors

Lead Sponsor

All Listed Sponsors
lead

EMD Serono

INDUSTRY

NCT00109733 - Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency | Biotech Hunter | Biotech Hunter