NCT01068639

Brief 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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 26, 2014

Status Verified

June 1, 2014

Enrollment Period

2 months

First QC Date

February 12, 2010

Last Update Submit

June 25, 2014

Conditions

Growth Hormone DisorderGrowth Hormone Deficiency in Children

Outcome Measures

Primary Outcomes (1)

  • Average number of injections omitted during the previous month

    measured over the past 2 months (retrospective data collection)

Study Arms (1)

A

Behavioral: No treatment given

Interventions

No treatment givenBEHAVIORAL

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

A

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children treated for at least one year with growth hormone with any growth hormone product whatever the reason for prescription

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2010

First Posted

February 15, 2010

Study Start

February 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 26, 2014

Record last verified: 2014-06