A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin
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).
|Study Design:||Time Perspective: Retrospective|
|Official Title:||Open-label, Multicenter, Observational, Non-intervention Study to Retrospectively Evaluate the Efficacy of Norditropin® (Adult Height) in Patients With Achondroplasia/Hypochondroplasia Enrolled in the GH-1941 Study [Follow-up Survey]|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||May 1997|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Dosage and administration to be prescribed by the physician as a result of a normal clinical practice.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435629
|Tokyo, Japan, 1000005|
|Study Director:||Global Clinical Registry (GCR, 1452)||Novo Nordisk Pharma Ltd.|