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Special Survey for Long Term Application
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01516229
First received: January 19, 2012
Last updated: February 23, 2017
Last verified: February 2017
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Purpose
This study is conducted in Japan. The aim of this study is to assess the incidence rate of adverse drug reactions (ADRs) when using somatropin (Norditropin®) for treatment of for achondroplasia without epiphyseal line closure under normal clinical practice conditions.
| Condition | Intervention |
|---|---|
| Genetic Disorder Achondroplasia | Drug: somatropin |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Specific Survey of Norditropin® in Achondroplasia: Survey for Long-term Application |
Resource links provided by NLM:
Genetics Home Reference related topics:
achondroplasia
Drug Information available for:
Somatropin
Genetic and Rare Diseases Information Center resources:
Achondroplasia
Mucopolysaccharidosis Type IV
U.S. FDA Resources
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- Incidence of adverse drug reactions (ADRs)
Secondary Outcome Measures:
- Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective
| Enrollment: | 395 |
| Actual Study Start Date: | May 1, 1997 |
| Study Completion Date: | March 31, 2007 |
| Primary Completion Date: | March 31, 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Somatropin |
Drug: somatropin
Prescription of somatropin at the discretion of the physician
|
Eligibility| Ages Eligible for Study: | 1 Year to 15 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients being treated with somatropin for achondroplasia without epiphyseal line closure
Criteria
Inclusion Criteria:
- Achondroplasia without epiphyseal line closure
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516229
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516229
Locations
| Japan | |
| Novo Nordisk Investigational Site | |
| Tokyo, Japan, 1000005 | |
| Novo Nordisk Investigational Site | |
| Tokyo, Japan, 103 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
More Information
Additional Information:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01516229 History of Changes |
| Other Study ID Numbers: |
GH-1941 |
| Study First Received: | January 19, 2012 |
| Last Updated: | February 23, 2017 |
Additional relevant MeSH terms:
|
Achondroplasia Dwarfism Bone Diseases, Developmental Bone Diseases |
Musculoskeletal Diseases Osteochondrodysplasias Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on July 28, 2017