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A Post Marketing Surveillance Program for NutropinAq® in Paediatric Growth Disorders (iNCGS)

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ClinicalTrials.gov Identifier: NCT00455728
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in Austria, France, Germany, Italy, Spain, Romania and United Kingdom to collect long-term safety and effectiveness information on NutropinAq® during treatment of paediatric growth disorders.

Condition or disease
Growth Hormone Disorders

Detailed Description:
The objective of this study is to collect long term safety and effectiveness information on Ipsen's growth hormone (GH) NutropinAq® regarding treatment of paediatric growth disorders for which GH is indicated.

Study Type : Observational
Actual Enrollment : 3690 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Cooperative Growth Study (iNCGS) Post Marketing Surveillance Program for NutropinAq® [Somatropin (rDNA Origin) Injection]
Actual Study Start Date : June 2006
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Growth Disorders




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Every 3 months until study completion ]
    Description and incidence of any Serious Adverse Event (SAE) and all related (serious and non-serious) Adverse Events (AEs).


Secondary Outcome Measures :
  1. Treatment height measurements until epiphyseal closure is achieved. [ Time Frame: Every 3 months until study completion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children treated with NutropinAq in the specialised paediatric endocrinology centres
Criteria

Inclusion Criteria:

  • Children of either sex who are treated with NutropinAq® for the treatment of growth failure
  • Patients who are willing to comply with follow-up appointments throughout study participation
  • Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable, and by the child when applicable

Exclusion Criteria:

  • Patients not treated with NutropinAq®
  • Patients with closed epiphyses
  • Patients with active neoplasia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455728


Locations
United Kingdom
Ipsen Central Contact
Slough, Berkshire, United Kingdom, SL1 3XE
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Caroline Sert, MD Ipsen

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00455728     History of Changes
Other Study ID Numbers: 2-79-58035-005
EUPAS7948 ( Registry Identifier: EU PAS Register )
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017