Growth Hormone Treatment in Short Children Born Small for Gestational Age

Phase 3CompletedNCT00191529

Eli Lilly and Company200 enrolled

Overview

Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Infant, Small for Gestational Age

Interventions

somatropinDRUG

Eligibility

Sex: ALLMin age: 3 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Born small for gestational age * actual body height less than or equal -3 SDS * chronological age greater than 3 years Exclusion Criteria: * Growth hormone deficiency * any defined syndromal disease * Diabetes mellitus

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Cologne, Germany

Outcomes

Primary Outcomes

The 2 different doses used are non-inferior to each other

Secondary Outcomes

Safety profiles

Compare absolute height velocity

Data from ClinicalTrials.gov

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