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Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation

NCT01073605 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2010-11-18

Study results available
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Summary

To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation

Conditions

  • Growth Disorders
  • Intrauterine Growth Retardation

Interventions

DRUG

Genotonorm

0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection

DRUG

Genotonorm

1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection

DRUG

Genotonorm

1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1993-07-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01073605 on ClinicalTrials.gov