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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00917514
First Posted: June 10, 2009
Last Update Posted: February 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medicpen AB
  Purpose
This is a study of the electronical dosing tool MedicPen and it's qualities with regards to user friendliness and medication compliance.

Condition
Crohn's Disease Ulcerative Colitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Medicpen AB:

Primary Outcome Measures:
  • User friendliness of Dosing Tool MedicPen [ Time Frame: June 2009 to Nov 2009 ]

Secondary Outcome Measures:
  • Measure treatment compliance [ Time Frame: June 2009 to Nov 2009 ]

Enrollment: 25
Study Start Date: June 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917514


Locations
Sweden
Department for Gastrointestinal medicin Karolinska University Hospital
Huddinge, Sweden, 141 86
Sponsors and Collaborators
Medicpen AB
Investigators
Principal Investigator: Mikael Lördal, Cheif MD Department for Gastrointestinal Medicine, Karolinska University Hospital, Huddinge
  More Information

Additional Information:
Responsible Party: CEO Cristian Hallin, MedicPen AB
ClinicalTrials.gov Identifier: NCT00917514     History of Changes
Other Study ID Numbers: MP-01
First Submitted: June 9, 2009
First Posted: June 10, 2009
Last Update Posted: February 26, 2010
Last Verified: June 2009

Keywords provided by Medicpen AB:
Dosing Tool
Compliance
User Friendly
Crohn's Disease
Ulcerative Colitis

Additional relevant MeSH terms:
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes