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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00455728
Other study ID # 2-79-58035-005
Secondary ID EUPAS7948
Status Completed
Phase
First received
Last updated
Start date June 2006
Est. completion date December 2016

Study information

Verified date January 2019
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT00455884 - A Post Marketing Surveillance Study for NutropinAq® in Adults With Growth Hormone Deficiency