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

Completed

• Conditions: Crohn's Disease; Ulcerative Colitis

• Registration Number: NCT00917514
• Lead Sponsor: Medicpen AB

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.

Study Timeline

• Status Verified: 2009-06
• Study Start: 2009-06
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-10
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-25
• Last Update Posted: 2010-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
User friendliness of Dosing Tool MedicPen	June 2009 to Nov 2009

Secondary Outcome Measures

Name	Time	Method
Measure treatment compliance	June 2009 to Nov 2009

Trial Locations

Locations (1)

Department for Gastrointestinal medicin Karolinska University Hospital; 🇸🇪 Huddinge, Sweden