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

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

Study Overview

• Status: Completed
• Conditions: Crohn's Disease; Ulcerative Colitis

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Sweden
  • Huddinge, Sweden, 141 86
    • Department for Gastrointestinal medicin Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Chrohn's disease or Ulcerative Colitis. Male or Female above 18 years of age. Ability to provide written informed consent. Must have been on Azathioprine treatment for at least 6 months prior to study start.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Measure treatment compliance	June 2009 to Nov 2009

Collaborators and Investigators

• Sponsor: Medicpen AB
• Investigators: Principal Investigator: Mikael Lördal, Cheif MD, Department for Gastrointestinal Medicine, Karolinska University Hospital, Huddinge

Publications and helpful links

Helpful Links

• Homepage of sponsor

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: June 9, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (Estimate): June 10, 2009

Study Record Updates

• Last Update Posted (Estimate): February 26, 2010
• Last Update Submitted That Met QC Criteria: February 25, 2010
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Compliance; Crohn's Disease; Dosing Tool; User Friendly
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Crohn Disease; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: MP-01