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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01068639
Other study ID # GH-3787
Secondary ID U1111-1113-2490
Status Withdrawn
Phase N/A
First received February 12, 2010
Last updated June 25, 2014
Start date February 2010
Est. completion date April 2010

Study information

Verified date June 2014
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Outcome

Type Measure Description Time frame Safety issue
Primary Average number of injections omitted during the previous month measured over the past 2 months (retrospective data collection) No
See also
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Recruiting NCT02616562 - Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency Phase 2
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