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NCT01110928

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

Completed Last updated 11 January 2019
What this trial tests

trial testing somatropin in Foetal Growth Problem in 227 participants. Completed in 12 November 2018.

Timeline
26 November 2009
Primary endpoint
12 November 2018
12 November 2018

Quick facts

Lead sponsorNovo Nordisk A/S
StatusCompleted
Study typeOBSERVATIONAL
Enrollment227
Start date26 November 2009
Primary completion12 November 2018
Estimated completion12 November 2018
Sites1 location across Japan

Drugs / interventions tested

Conditions studied

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Eligibility, any sex, with Foetal Growth Problem or Small for Gestational Age. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The long-term safety and effectiveness of growth hormone treatment in Japanese children with short stature born small for gestational age.
    Horikawa R, Tanaka T, Nishinaga H, Nishiba Y, et al · · 2020 · cited 17× · PMID 33088015 · DOI 10.1297/cpe.29.159

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Other trials of somatropin

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01110928.

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