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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Crohn's Disease Ulcerative Colitis

Keywords

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Dosing Tool Compliance User Friendly Crohn's Disease Ulcerative Colitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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MedicPen AB

Principal Investigators

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Mikael Lördal, Cheif MD

Role: PRINCIPAL_INVESTIGATOR

Department for Gastrointestinal Medicine, Karolinska University Hospital, Huddinge

Locations

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Department for Gastrointestinal medicin Karolinska University Hospital

Huddinge, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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MP-01

Identifier Type: -

Identifier Source: org_study_id