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NCT00917514 Clinical Trial

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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00917514
Other study ID # MP-01
Secondary ID
Status Completed
Phase N/A
First received June 9, 2009
Last updated February 25, 2010
Start date June 2009
Est. completion date February 2010

Study information
Verified date June 2009
Source Medicpen AB
Contact n/a
Is FDA regulated No
Health authority Sweden: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Department for Gastrointestinal medicin Karolinska University Hospital Huddinge

Sponsors (1)
Lead Sponsor Collaborator
Medicpen AB

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary User friendliness of Dosing Tool MedicPen June 2009 to Nov 2009 No
Secondary Measure treatment compliance June 2009 to Nov 2009 No
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