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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00455728
First received: April 3, 2007
Last updated: July 20, 2016
Last verified: July 2016
  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 Phase
Growth Hormone Disorders
Phase 4

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 5250
Study Start Date: June 2006
Estimated Study Completion Date: December 2099
Estimated Primary Completion Date: December 2099 (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)
Genders Eligible for Study:   Both
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

Contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
United Kingdom
Ipsen Central Contact Recruiting
Slough, Berkshire, United Kingdom, SL1 3XE
Contact       clinical.trials@ipsen.com   
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: July 20, 2016
Health Authority: France: French Data Protection Authority
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
Spain: Spanish Agency of Medicines
Romania: Ethics Committee
Romania: National Agency for Medicines and Medical Devices
Austria: Federal Office for Safety in Health Care

ClinicalTrials.gov processed this record on December 09, 2016