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

Achondroplasia Clinical Trial

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435629
• Other study ID #: GH-3907
• Secondary ID: U1111-1121-7729J
• Status: Completed
• Phase: N/A
• First received: September 14, 2011
• Last updated: May 4, 2017
• Start date: November 22, 2012
• Est. completion date: December 4, 2015

Study information

• Verified date: May 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 4, 2015
• Est. primary completion date: December 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Achondroplasia
• Genetic Disorder

Intervention

Drug:
• somatropin
Dosage and administration to be prescribed by the physician as a result of a normal clinical practice.

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect change data of adult height (cm) of patients treated with Norditropin® and evaluate the long-term efficacy		At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age
Secondary	To monitor the patients to see if they undergo lower limb lengthening		At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age

External Links

•   Clinical Trials at Novo Nordisk