A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01435629
• Date of registration: 14/09/2011
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin
• Scientific 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]
• Date of first enrolment: November 22, 2012
• Target sample size: 81
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01435629
• Study type: Observational
• Phase: N/A

Countries of recruitment

Japan

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who were enrolled in the GH-1941 study (1997 to 2006) and expected to
theoretically reach the adult height within the study period



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Achondroplasia

Genetic Disorder

Intervention(s)

Drug: somatropin

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

U1111-1121-7729

GH-3907

JapicCTI-111622

Source(s) of Monetary Support

Please refer to primary and secondary sponsors