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Completed

NCT Number: NCT00917514

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

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

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Key information

Conditions

Crohn's Disease Behavior Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Health Behavior Inflammatory Bowel Diseases Intestinal Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Ulcerative Colitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department for Gastrointestinal medicin Karolinska University Hospital

Huddinge, 141 86, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. User friendliness of Dosing Tool MedicPen

    Time frame: June 2009 to Nov 2009

Secondary outcomes

  1. Measure treatment compliance

    Time frame: June 2009 to Nov 2009

Sponsors and collaborators

Lead sponsor

Medicpen AB

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 10, 2009
Registry last updated
Feb 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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