Special Survey for Long Term Application
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ClinicalTrials.gov Identifier: NCT01516229 |
Recruitment Status :
Completed
First Posted : January 24, 2012
Last Update Posted : February 27, 2017
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Condition or disease | Intervention/treatment |
---|---|
Genetic Disorder Achondroplasia | Drug: somatropin |
Study Type : | Observational |
Actual Enrollment : | 395 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Specific Survey of Norditropin® in Achondroplasia: Survey for Long-term Application |
Actual Study Start Date : | May 1, 1997 |
Actual Primary Completion Date : | March 31, 2007 |
Actual Study Completion Date : | March 31, 2007 |

Group/Cohort | Intervention/treatment |
---|---|
Somatropin |
Drug: somatropin
Prescription of somatropin at the discretion of the physician |
- Incidence of adverse drug reactions (ADRs)
- Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective

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Ages Eligible for Study: | 1 Year to 15 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Achondroplasia without epiphyseal line closure

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): NCT01516229
Japan | |
Novo Nordisk Investigational Site | |
Tokyo, Japan, 1000005 | |
Novo Nordisk Investigational Site | |
Tokyo, Japan, 103 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01516229 |
Other Study ID Numbers: |
GH-1941 |
First Posted: | January 24, 2012 Key Record Dates |
Last Update Posted: | February 27, 2017 |
Last Verified: | February 2017 |
Achondroplasia Genetic Diseases, Inborn Dwarfism Bone Diseases, Developmental |
Bone Diseases Musculoskeletal Diseases Osteochondrodysplasias |