Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome
NordiPAD
A Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs.
1 other identifier
observational
2,016
1 country
1
Brief Summary
This study is conducted in Japan. The aim of this study is to collect information about the efficacy and safety of Norditropin® (somatropin) in the long-term treatment of short stature with GHD (Growth Hormone Deficiency) where epiphysial discs are not closed and short stature with Turner Syndrome where epiphysial discs are not closed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJuly 3, 2015
July 1, 2015
10.1 years
May 21, 2012
July 2, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in height
Week 0, Month 36, final height is reached
Incidence of adverse reactions (ADRs)
36 months, accumulation of study period
Study Arms (1)
Somatropin
Interventions
Collection of safety and efficacy data in connection with use of somatropin (Norditropin®) in daily clinical practice.
Eligibility Criteria
Patients from normal practice who have been deemed appropriate to receive somatropin ( Norditropin®) as part of routine out-patient care by the prescribing physician.
You may qualify if:
- Growth hormone deficiency or short stature due to Turner Syndrome where the epiphyseal discs are not closed
You may not qualify if:
- Diabetic
- Patients with malignant tumors
- Women who are either pregnant or likely to be pregnant
- Known or suspected allergy to study product(s) or related products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Tokyo, 1000005, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 23, 2012
Study Start
May 1, 2005
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 3, 2015
Record last verified: 2015-07