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

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ClinicalTrials.gov Identifier: NCT01435629
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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

Study Design
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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

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Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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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 ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
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
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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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 ClinicalTrials.gov identifier (NCT number): NCT01435629


Locations
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01435629     History of Changes
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:
Genetic Diseases, Inborn
Achondroplasia
Dwarfism
Bone Diseases, Developmental
 Bone Diseases
Musculoskeletal Diseases
Osteochondrodysplasias