NordiPAD: Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome
Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01604161
Collaborator
(none)
2,016
1
121
16.7
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
2016 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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.
Study Start Date
:
May 1, 2005
Actual Primary Completion Date
:
Jun 1, 2015
Actual Study Completion Date
:
Jun 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Somatropin
|
Drug: somatropin
Collection of safety and efficacy data in connection with use of somatropin (Norditropin®) in daily clinical practice.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in height [Week 0, Month 36, final height is reached]
- Incidence of adverse reactions (ADRs) [36 months, accumulation of study period]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Growth hormone deficiency or short stature due to Turner Syndrome where the epiphyseal discs are not closed
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tokyo | Japan | 1000005 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01604161
Other Study ID Numbers:
- GH-3910
First Posted:
May 23, 2012
Last Update Posted:
Jul 3, 2015
Last Verified:
Jul 1, 2015
Additional relevant MeSH terms: