Special Survey for Long Term Application
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01516229
First received: January 19, 2012
Last updated: June 26, 2012
Last verified: January 2012
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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
Meier-Gorlin syndrome
metatropic dysplasia
mucopolysaccharidosis type IV
pseudoachondroplasia
Drug Information available for:
Somatropin
U.S. FDA Resources
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- Incidence of adverse drug reactions (ADRs) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective [ Designated as safety issue: No ]
| Enrollment: | 395 |
| Study Start Date: | May 1997 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | March 2006 (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 |
| Genders Eligible for Study: | Both |
| 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 | |
| Tokyo, Japan, 103 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Masayuki Senda | Novo Nordisk Pharma Ltd. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, 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: | June 26, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Achondroplasia Bone Diseases Bone Diseases, Developmental Dwarfism |
Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias |
ClinicalTrials.gov processed this record on March 03, 2015