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OpenTrials
Completed

NCT Number: NCT00455728

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

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.

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Key information

Conditions

Growth Hormone Disorders

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ipsen Central Contact

Slough, Berkshire, SL1 3XE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Treatment height measurements until epiphyseal closure is achieved.

    Time frame: Every 3 months until study completion

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Acronym: iNCGS

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2007
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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