CompletedNot Applicable

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

Japan227 participantsStarted 2009-11-26

Plain-language summary

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).

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number and type of suspected serious adverse drug reactions (SADRs) during the study period

Timeframe: evaluated binannually for 9 years

Trial details

NCT IDNCT01110928

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-11-12

View on ClinicalTrials.gov More Foetal Growth Problem trials