An Investigational Study to Test Usability of the Electronic Dosing Equipment Medicpen

An Investigational Study to Test Usability of the Electronic Dosing Equipment Medicpen During Azathioprine Treatment in Patients With Crohn's Disease or Ulcerative Colitis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00917514

Enrollment

Registered

2009-06-10

Start date

2009-06-30

Completion date

2010-02-28

Last updated

2010-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease, Ulcerative Colitis

Keywords

Dosing Tool, Compliance, User Friendly, Crohn's Disease, Ulcerative Colitis

Brief summary

This is a study of the electronical dosing tool MedicPen and it's qualities with regards to user friendliness and medication compliance.

Detailed description

The medical device MedicPen will be investigated for it's qualities with regards to medication compliance and user friendliness. The patient group selected here is patients with Crohn's disease that are treated with Azathioprine. The patient selection was made since the metabolite can be easily measured and the compliance can be therefore be followed. The treatment will follow the standard care given to these patients.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female * 18 years or older * Provided written informed consent * Diagnosed with Chron's disease or Ulcerative Colitis * Treated with Azathiprine for at least 6 months prior to study start

Exclusion criteria

* Patients who are, for some reason, judged by the responsible investigator to be unable to handle the device to be tested.

Design outcomes

Primary

Measure	Time frame
User friendliness of Dosing Tool MedicPen	June 2009 to Nov 2009

Secondary

Measure	Time frame
Measure treatment compliance	June 2009 to Nov 2009

Countries

Sweden

Outcome results