Observational Prospective Study on Patients Treated With Norditropin®


Tracking Information

Start Date  ICMJEApril 2006
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: August 14, 2009)
  • Effect of Norditropin® treatment on height gain (change in height) in children [ Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 3 years in accordance with defined duration of the study. ] [ Designated as safety issue: No ]
  • Effect of Norditropin® treatment on body weight and body composition in adults [ Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 3 years in accordance with defined duration of the study. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00960128 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: August 14, 2009)
  • Effect of Norditropin® treatment on glucose metabolism, body weight, blood biochemistry, bone age, primary tumour occurrence or reoccurrence, the endocrine system and pubertal development in children [ Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 3 years in accordance with defined duration of the study. ] [ Designated as safety issue: Yes ]
  • Effect of Norditropin® treatment on quality of life, glucose metabolism, tumour status, blood biochemistry and the endocrine system in adults [ Time Frame: Study outcomes (study endpoints) will be analysed and reported on annual basis. The mean follow up period for study outcomes is expected to be 3 years in accordance with defined duration of the study. ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEObservational Prospective Study on Patients Treated With Norditropin®
Official Title  ICMJENordiNet® International Outcome Study-Observational Prospective Study on Patients Treated With Norditropin®
Brief Summary

This study is conducted in Europe. The aim of this observational study is to investigate the effectiveness and safety of real-life treatment with Norditropin®. The study population will consist of children and adults who are already being treated with Norditropin® or who are candidates for treatment with Norditropin®.

Detailed Description 
Study Phase 
Study Type  ICMJEObservational
Study Design  ICMJECohort, Prospective
Condition  ICMJE
  • Growth Hormone Deficiency (GHD)
  • Growth Hormone Deficiency, Adults (GHDA)
  • Turner Syndrome
  • Small for Gestational Age (SGA)
  • Chronic Renal Insufficiency
  • Noonan Syndrome
Intervention  ICMJE
  • Drug: somatropin
    The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with adults.
  • Drug: somatropin
    The effectiveness and safety data collection with the use of Norditropin® in daily clinical practice with children.
Study Arms / Comparison Groups
  • A
    Adult cohort
    Intervention: Drug: somatropin
  • B
    Paediatric cohort
    Intervention: Drug: somatropin

Recruitment Information

Estimated Enrollment  ICMJE10000
Estimated Completion DateMarch 2011
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Judged by the physician as per the Norditropin® label

Exclusion Criteria:

  • Judged by the physician as per the Norditropin® label
GenderBoth
Ages 
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Public Access to Clinical Trials - Novo NordiskPlease Contact NN via emailclinicaltrials@novonordisk.com
Location Countries  ICMJEArgentina,   Brazil,   Czech Republic,   Denmark,   Finland,   Former Serbia and Montenegro,   France,   Germany,   Hungary,   Ireland,   Italy,   Lithuania,   Netherlands,   Norway,   Russian Federation,   Saudi Arabia,   Slovenia,   Sweden,   Switzerland,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00960128
Responsible PartyPublic Access to Clinical Trials, Novo Nordisk A/S
Study ID Numbers  ICMJEGHLIQUID-3676
Study Sponsor  ICMJENovo Nordisk
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Viatcheslav Rakov, MDNovo Nordisk Health Care AG
Information Provided ByNovo Nordisk