Clinical Trial: A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Open-label, Multicenter, Observational, Non-intervention Study to Retrospectively Evaluate the Efficacy of Norditropin® (Adult Height) in Patients With Achondroplasia
Brief Summary: This study is conducted in Japan. The aim of the study is to evaluate the efficacy of somatropin (Norditropin®) on adult height (cm) in patients with achondroplasia / hypochondroplasia enrolled in the GH-1941 study (NCT01516229).
Detailed Summary:
Sponsor: Novo Nordisk A/S
Current Primary Outcome: To collect change data of adult height (cm) of patients treated with Norditropin® and evaluate the long-term efficacy [ Time Frame: At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To monitor the patients to see if they undergo lower limb lengthening [ Time Frame: At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age ]
Original Secondary Outcome: Same as current
Information By: Novo Nordisk A/S
Dates:
Date Received: September 14, 2011
Date Started: November 22, 2012
Date Completion:
Last Updated: May 4, 2017
Last Verified: May 2017