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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01435629
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : May 5, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

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).

Condition or disease Intervention/treatment
Genetic Disorder Achondroplasia Drug: somatropin

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Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Other
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]
Actual Study Start Date : November 22, 2012
Actual Primary Completion Date : December 4, 2015
Actual Study Completion Date : December 4, 2015

Group/Cohort Intervention/treatment
Norditropin® Drug: somatropin
Dosage and administration to be prescribed by the physician as a result of a normal clinical practice.

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01435629

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Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S Identifier: NCT01435629    
Other Study ID Numbers: GH-3907
U1111-1121-7729 ( Other Identifier: WHO )
JapicCTI-111622 ( Other Identifier: JAPIC )
First Posted: September 16, 2011    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Genetic Diseases, Inborn
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases