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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: September 14, 2011
Last updated: January 14, 2016
Last verified: January 2016
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).

Condition Intervention
Genetic Disorder
Drug: somatropin

Study Type: Observational
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]

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 54
Study Start Date: May 1997
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Norditropin® Drug: somatropin
Dosage and administration to be prescribed by the physician as a result of a normal clinical practice.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled in the GH-1941 study (NCT01516229) expected to achieve the adult height by 2015 and available for follow-up by the investigator

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01435629

Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01435629     History of Changes
Other Study ID Numbers: GH-3907  U1111-1121-7729  JapicCTI-111622 
Study First Received: September 14, 2011
Last Updated: January 14, 2016
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Developmental
Genetic Diseases, Inborn
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 25, 2016