Clinical Trials Logo
  1. Home
  2. Turner Syndrome
  3. NCT01543867
  4. Details
NCT01543867 Clinical Trial

Safety and Efficacy of Long-term Somatropin Treatment in Children

Turner Syndrome Clinical Trial

— GrowthWIN II  

Official title:
Non-interventional Study of the Safety and Efficacy of Long-term Somatropin Treatment in Children (GrowthWIN II / GrowthWIN II SGA)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01543867
Other study ID # GH-1930
Secondary ID
Status Completed
Phase N/A
First received February 28, 2012
Last updated March 27, 2015
Start date January 2001
Est. completion date December 2011

Study information
Verified date March 2015
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

This study is conducted in Europe. The aim of this study is to evaluate safety during the long-term use of somatropin (Norditropin®) in children as well as efficacy on change in height. A subgroup of children small for their gestational age is included.

Recruitment information / eligibility
Status Completed
Enrollment 5442
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- In need of somatropin or current user

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin
Prescribed at the discretion of the treating physician according to product labelling

Locations
Country Name City State
n/a

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

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of adverse events Up to 10 years No
Secondary Number of patients continuing somatropin treatment Up to 10 years No
Secondary Change in height Up to 10 years No
Secondary Onset of puberty in children small for gestational age Up to 10 years No
Secondary Co-morbidities in children small for gestational age Up to 10 years No
See also
  Status Clinical Trial Phase
Completed NCT01734486 - Growth Response in Girls With Turner Syndrome Phase 4
Completed NCT01678261 - X-chromosome Inactivation, Epigenetics and the Transcriptome N/A
Completed NCT01419249 - First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study Phase 4
Completed NCT01518036 - Use of Somatropin in Turner Syndrome Phase 3
Recruiting NCT04948658 - Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Completed NCT01563926 - Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency Phase 3
Completed NCT02787486 - Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
Completed NCT00877942 - Sex Differences in Early Brain Development; Brain Development in Turner Syndrome N/A
Completed NCT00825617 - Quantitative Liver Functions in Turner Syndrome With and Without Hormone Replacement Therapy N/A
Recruiting NCT04463316 - GROWing Up With Rare GENEtic Syndromes
Enrolling by invitation NCT03836300 - Parent and Infant Inter(X)Action Intervention (PIXI) N/A
Completed NCT01245374 - Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents Phase 4
Completed NCT01322165 - National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions N/A
Terminated NCT00419107 - Beta Cell Function in Women With Turner Syndrome N/A
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

External Links