CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
Somatropin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Prepubertal caucasian boys aged 4–10 years or girls aged 4–9 years
  • ✓Tanner stage 1 breast development (girls) and testis volume ≤3 ml (boys)
  • ✓Tanner stage 1 pubic hair development
  • ✓Height ≤-2 SD for chronological age (Brandt/Reinken)
Key exclusion· 9
  • ✕Other endocrine diseases except well-substituted hypothyroidism
  • ✕Severe chronic diseases or medications affecting linear growth or insulin sensitivity (e.g., glucocorticoids)
  • ✕Positive GAD and IA-2 antibodies (type 1 diabetes screening)
  • ✕History of malignancy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00174460
NCT00174460Phase 2Completed
CompareCT.gov

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

Pfizer·interventional·Posted Sep 15, 2005·Updated Apr 5, 2017

In Brief

A Phase 2 clinical trial evaluating Somatropin and Control Arm for Growth Hormone Therapy and Infant, Very Low Birth Weight. Completed, enrolled 33 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGrowth Hormone Therapy, Infant, Very Low Birth Weight
CountriesGermany
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartAug 1, 2005
Primary CompletionMar 1, 2008
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 20.8 years ago

Interventions

Somatropindrug

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.

Control Armother

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.