Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome
Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome
Evaluate the efficacy and safety after treatment of Eutropin® inj. compared to Genotropin® in
 infants/toddlers with Prader-Willi syndrome
-  Inclusion Criteria:

 1. Pediatric patients with PWS confirmed by methylation PCR genetic testing

 2. Prepubertal pediatric patients (Tanner's Pubertal stage I) at screening

 3. Pediatric patients who have never been treated with hGH prior to screening, or
 who had been treated with hGH for less than 6 months if they had a treatment
 history, and whose last administration was made 6 months prior to screening

 4. Pediatric patients with normal thyroid function at screening (Those with normal
 function through a hormonal therapy were allowable.)

 5. Pediatric patients whose parents or LARs signed the informed consent form in
 writing after receiving the explanation about the purpose, method, effects, etc.
 of the clinical study, and who also signed the informed consent form in writing
 if they are capable of reading and understanding writing.

 -  Exclusion Criteria:

 1. Pediatric patients who are accompanied by other causes for growth retardation as
 follows except for PWS at screening

 : Chronic renal failure (including the case in which renal transplantation has
 been undergone), Silver-Russell syndrome, Turner's syndrome, Seckel syndrome,
 Down's syndrome, Noonan syndrome, Cushing's syndrome, congenital infections,
 psychiatric disorders, chronic debilitating diseases, etc.

 2. Pediatric patients with malignancy or a history of malignancy at screening

 3. Pediatric patients with severe respiratory disturbance, or sleep apnoea or a
 history of respiratory infections with an unknown cause at screening. However,
 those whose condition had been confirmed to be eligible to participate in the
 clinical study on investigator's judgment were allowed to participae in the
 study.

 4. Pediatric patients with impaired fasting glucose, diabetes, and diabetic
 retinopathy at screening

 5. Pediatric patients whose epiphyses are closed with a growth rate of ≤1 cm/year at
 screening

 6. Pediatric patients who are being administered any drug that may have an effect on
 the secretion and actions of hGH (estrogen, androgen, anabolic steroids,
 corticosteroids, GnRH analogs, thyroxine, aromatase inhibitors, etc.) or
 anticonvulsants and cyclosporin at screening, and have been administered any of
 them for a long period of time within 6 months prior to screening (However, those
 who have been administered a thyroxine preparation for ≥4 weeks on a stable dose
 [allowable in case the investigator determines the dose is stable even though it
 is changeable based upon the weight of the pediatric patient] were allowed to
 participate in the clinical study.)

 7. Pediatric patients who are being administered any drug (e.g. methylphenidate) for
 treatment of hyperactivity disorders including attention deficit hyperactivity
 disorder (ADHD) at screening

 8. Pediatric patients who are hypersensitive to somatropin or any excipient of the
 investigational product (cresol or glycerol) or who have a relevant history of
 hypersensitivity

 9. Pediatric patients who have participated in any other clinical studies after
 enrolled in this study or who had participated in any other clinical studies
 within 3 months prior to enrollment in this clinical study

 10. Pediatric patients in whom this clinical study is considered to be difficult to
 be conducted for any other reasons on investigator's judgment