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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00455728
First received: April 3, 2007
Last updated: January 30, 2017
Last verified: January 2017
  Purpose
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
Growth Hormone Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Cooperative Growth Study (iNCGS) Post Marketing Surveillance Program for NutropinAq® [Somatropin (rDNA Origin) Injection]

Resource links provided by NLM:


Further study details as provided by Ipsen:

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

Enrollment: 3690
Actual Study Start Date: June 2006
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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.
  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455728

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

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00455728     History of Changes
Other Study ID Numbers: 2-79-58035-005
Study First Received: April 3, 2007
Last Updated: January 30, 2017

ClinicalTrials.gov processed this record on September 19, 2017