Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary

Phase 3CompletedNCT00174278

Pfizer14 enrolled

Overview

To assess the effect of long-term treatment by Genotonorm on linear growth

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Growth Hormone Deficiency Growth Retardation

Interventions

SomatropinDRUG

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014 * All patients who have stopped during one year will be included if a signed written informed consent Exclusion Criteria: * Endocrine disease, except well substituted hypothyroidism * Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)

Locations (1)

Pfizer Investigational Site

Paris, France

Outcomes

Primary Outcomes

The main efficacy variable is the height SDS (SEMPE) before and after treatment.

The standing height of the patients is measured during the inclusion visit and at each follow-up visit.

The height measurements are always performed at the same time of the day by

use of a wallmounted device (e.g. Harpenden Stadiometer).

Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.

The body weight is measured by use of a balance scale.

Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.

Data from ClinicalTrials.gov

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