Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-26

Study Completion Date

2018-11-12

Brief Summary

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This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial (NCT00184717).

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Detailed Description

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Conditions

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Foetal Growth Problem Small for Gestational Age

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Norditropin®

somatropin

Intervention Type DRUG

Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, at study initiation and every 6 months until last visit.

Interventions

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somatropin

Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, at study initiation and every 6 months until last visit.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participation in the GHLIQUID-1517 trial
* Patients with SGA (small for gestational age) short stature that are still growing

Exclusion Criteria

* Known or suspected allergy to study product(s) or related products
* Diabetes Mellitus
* Patients with malignant tumor(s)
* Pregnant or likely to get pregnant

Eligible Sex

ALL

Accepts Healthy Volunteers

No