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

This study is currently recruiting participants.
Verified February 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00455728
First received: April 3, 2007
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

This study is a multicenter, open label, observational, post marketing surveillance study of NutropinAq® in France, Germany, Italy, Spain, Romania and United Kingdom


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 ]

Secondary Outcome Measures:
  • Post-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 efficacy 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
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 in France, Germany, Spain, Italy, Romania and UK.

Criteria

Inclusion Criteria:

  • Children of either sex who are treated with NutropinAq® for the treatment of growth failure
  • Patients who are willing to keep follow up appointments throughout study participation

Exclusion Criteria:

  • Patients not treated with NutropinAq®
  • Patients with closed epiphyses
  • Patients with active neoplasia
  Contacts and Locations
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: Christine Massien, MD Ipsen
  More Information

No publications provided

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: February 27, 2014
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

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014