NCT00174460

Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age

Somatropin Therapy For Short Children Born Of Premature Gestation, A Controlled, Prospective Randomized, Multicenter Study With An Untreated Control Group.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.

Conditions

• Growth Hormone Therapy
• Infant, Very Low Birth Weight

Interventions

Type	Name	Description
DRUG	Somatropin	Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. Children randomized to the control group will get the possibility to continue treatment for a further year. The study will end after 2 and 3 years of observation, respectively.
OTHER	Control Arm	Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. The study will end after 2 and 3 years of observation, respectively. Children randomized to the control group will get the possibility to continue treatment for a further year.

Timeline

• Start date: 2005-08-01
• Primary completion: 2008-03-01
• Completion: 2010-03-01
• First posted: 2005-09-15
• Last updated: 2017-04-05
• Results posted: 2009-05-12

Locations

8 sites across 1 country: Germany