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

This study has been completed.
Sponsor:
Information provided by:
Medicpen AB
ClinicalTrials.gov Identifier:
NCT00917514
First received: June 9, 2009
Last updated: February 25, 2010
Last verified: June 2009
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure treatment compliance [ Time Frame: June 2009 to Nov 2009 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: CEO Cristian Hallin, MedicPen AB
ClinicalTrials.gov Identifier: NCT00917514     History of Changes
Other Study ID Numbers: MP-01
Study First Received: June 9, 2009
Last Updated: February 25, 2010
Health Authority: Sweden: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014