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

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]

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01435629
Enrollment
81
Registered
2011-09-16
Start date
2012-11-22
Completion date
2015-12-04
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achondroplasia, Genetic Disorder

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).

Interventions

DRUGsomatropin

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

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To collect change data of adult height (cm) of patients treated with Norditropin® and evaluate the long-term efficacyAt year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age

Secondary

MeasureTime frame
To monitor the patients to see if they undergo lower limb lengtheningAt year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026