Clinical Trial Details
| Trial ID: | L1727 |
| Source ID: | NCT00960128 |
| Associated Drug: | Somatropin |
| Title: | Observational Prospective Study on Patients Treated With Norditropin® |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Growth Hormone Disorder|Growth Hormone Deficiency in Children|Adult Growth Hormone Deficiency|Genetic Disorder|Turner Syndrome|Foetal Growth Problem|Small for Gestational Age|Chronic Kidney Disease|Chronic Renal Insufficiency|Noonan Syndrome |
| Interventions: | DRUG: somatropin|DRUG: somatropin |
| Outcome Measures: | Primary: Effect of Norditropin® treatment on height gain (change in height) in children, Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.|Effect of Norditropin® treatment on body weight and body composition in adults, Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. | Secondary: Effect of Norditropin® treatment body weight, blood biochemistry, bone age, the endocrine system and pubertal development in children, Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study.|Effect of Norditropin® treatment on quality of life, blood biochemistry and the endocrine system in adults, Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 5 years in accordance with defined duration of the study. |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | CHILD, ADULT, OLDER_ADULT |
| Phases: | |
| Enrollment: | 21249 |
| Study Type: | OBSERVATIONAL |
| Study Designs: | Observational Model: |Time Perspective: p |
| Start Date: | 2006-04-01 |
| Completion Date: | 2016-12-31 |
| Results First Posted: | |
| Last Update Posted: | 2017-10-12 |
| Locations: | Novo Nordisk Investigational Site, Prov. de Buenos Aires, B1636DSU, Argentina|Novo Nordisk Investigational Site, Brussels, 1070, Belgium|Novo Nordisk Investigational Site, Prague, 16000, Czechia|Novo Nordisk Investigational Site, Copenhagen S, 2300, Denmark|Novo Nordisk Investigational Site, Espoo, FI-02600, Finland|Novo Nordisk Investigational Site, Paris La défense cedex, 92932, France|Novo Nordisk Investigational Site, Mainz, 55127, Germany|Novo Nordisk Investigational Site, Budapest, 1025, Hungary|Novo Nordisk Investigational Site, Dublin 2, Ireland|Novo Nordisk Investigational Site, Kfar Saba, 44425, Israel|Novo Nordisk Investigational Site, Rome, 00144, Italy|Novo Nordisk Investigational Site, Vilnius, 01112, Lithuania|Novo Nordisk Investigational Site, Luxembourg, Luxembourg|Novo Nordisk Investigational Site, Alphen a/d Rijn, Netherlands|Novo Nordisk Investigational Site, Rud, 1309, Norway|Novo Nordisk Investigational Site, Moscow, 119330, Russian Federation|Novo Nordisk Investigational Site, Riyadh, 3542, Saudi Arabia|Novo Nordisk Investigational Site, Belgrade, 11 070, Serbia|Novo Nordisk Investigational Site, Ljubljana, SI-1000, Slovenia|Novo Nordisk Investigational Site, Madrid, 28033, Spain|Novo Nordisk Investigational Site, Malmö, 202 15, Sweden|Novo Nordisk Investigational Site, Zurich, CH-8050, Switzerland|Novo Nordisk Investigational Site, Crawley, RH11 9RT, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT00960128 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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