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NCT01604161 Clinical Trial

Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome

Turner Syndrome Clinical Trial

— NordiPAD  

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01604161
Other study ID # GH-3910
Secondary ID
Status Completed
Phase N/A
First received May 21, 2012
Last updated July 2, 2015
Start date May 2005
Est. completion date June 2015

Study information
Verified date July 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2016
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin
Collection of safety and efficacy data in connection with use of somatropin (Norditropin®) in daily clinical practice.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in height Week 0, Month 36, final height is reached No
Primary Incidence of adverse reactions (ADRs) 36 months, accumulation of study period No
See also
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Completed NCT01245374 - Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents Phase 4
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Active, not recruiting NCT00625001 - Long Term Follow-up of Bone Mineral Density in Hormone Treated Turner Syndrome N/A
Completed NCT00029159 - The Effect of Androgen and Growth Hormone on Height and Learning in Girls With Turner Syndrome Phase 3
Completed NCT01518062 - Safety of Somatropin and Induction of Puberty With 17-beta-oestradiol in Girls With Turner Syndrome Phase 4
Completed NCT00471731 - Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure N/A
Completed NCT00256126 - Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN® Phase 4
Completed NCT03181230 - Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome

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