Clinical Trial: Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase III, Multi-center, Randomized, Comparative, Parallel, Open Study to Assess the Efficacy and Safety After Treatment of Eutropin® Inj. Compared to Genotropin® in Infants/Toddlers With
Brief Summary: Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in infants/toddlers with Prader-Willi syndrome
Detailed Summary:
Sponsor: LG Life Sciences
Current Primary Outcome:
- Change from baseline in height SDS (Standard Deviation Score) [ Time Frame: baseline and 52 weeks ]
- Change from baseline in Lean body mass [ Time Frame: baseline and 52 weeks ]
- Change from baseline in Percent body fat [ Time Frame: baseline and 52 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline in height velocity [ Time Frame: baseline, 16, 28 and 52 weeks ]
- Change from baseline in head circumference [ Time Frame: baseline, 16, 28 and 52 weeks ]
- Change from baseline in mental development by Bayley Scale [ Time Frame: baseline, 28 and 52 weeks ]
- Change from baseline in motor development by Bayley Scale [ Time Frame: baseline, 28 and 52 weeks ]
- Change from baseline in weight SDS [ Time Frame: baseline 16, 28 and 52 weeks ]
- Change from baseline in BMI (Body Mass Index) [ Time Frame: baseline, 16, 28 and 52 weeks ]
- Change from baseline in Bone age [ Time Frame: baseline and 52 weeks ]
- Change from baseline in Bone mineral density [ Time Frame: baseline and 52 weeks ]
Original Secondary Outcome: Same as current
Information By: LG Life Sciences
Dates:
Date Received: July 25, 2014
Date Started: June 2014
Date Completion: July 2017
Last Updated: September 11, 2015
Last Verified: September 2015