An Observational Study on Treatment Compliance by Children Treated With Growth Hormone

NCT01068639 — Withdrawn, Novo Nordisk A/S

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IMprove PAtient Compliance sTudy: An Observational, Cross-sectional Study on Children Treated With Growth Hormone in France

Registry	NCT01068639, acronym IMPACT
Status	Withdrawn
Study type	Observational
Sponsor	Novo Nordisk A/S (Industry)
Conditions	Growth Hormone Disorder, Growth Hormone Deficiency in Children
Interventions	No treatment given (Behavioral)
Dates	start 2010-02-01, primary completion 2010-04-01 (estimated), completion 2010-04-01 (estimated), first posted 2010-02-15, last updated 2014-06-26

-Summary

This study is conducted in Europe. This observational study aims at evaluating compliance with growth hormone treatment in children and identifying factors influencing compliance.

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+Arms and interventions

Arm	Type	Interventions	Description
A		Behavioral: No treatment given

No treatment given (Behavioral): No treatment given to study participants, only behaviorial patterns with respect to treatment compliance is observed.

+Outcome measures

Primary outcomes

Average number of injections omitted during the previous month [measured over the past 2 months (retrospective data collection)]

+Eligibility

Sex: All, ages: any to 18 Years

Inclusion Criteria:

* Child treated for at least one year with growth hormone any growth hormone product
* Followed by the participating paediatrician for at least 1 year.

Exclusion Criteria:

* Refusal to participate
* Child and/or parent unable to give consent or fill out the questionnaires
* Child participating in a therapeutic trial

+Investigators

Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S

My Notes

Public

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