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

Growth Hormone Disorders Clinical Trial

— iNCGS  

Official title:

International Cooperative Growth Study (iNCGS) Post Marketing Surveillance Program for NutropinAq® [Somatropin (rDNA Origin) Injection]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455728
• Other study ID #: 2-79-58035-005
• Secondary ID: EUPAS7948
• Status: Completed
• Start date: June 2006
• Est. completion date: December 2016

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3690
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Growth Hormone Disorders

Locations

Country	Name	City	State
United Kingdom	Ipsen Central Contact	Slough	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events	Description and incidence of any Serious Adverse Event (SAE) and all related (serious and non-serious) Adverse Events (AEs).	Every 3 months until study completion
Secondary	Treatment height measurements until epiphyseal closure is achieved.		Every 3 months until study completion