An Investigational Study to Test Usability of the Electro... | NCT00917514

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

NCT00917514

Sponsor

Medicpen AB

Status

Completed

Last Update Posted

Feb 26, 2010Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Crohn's Disease
Ulcerative Colitis

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Jun 9, 2009

First Submission Date that Met QC Criteria

Jun 9, 2009

First Posted Date

Jun 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2010

Last Update Posted Date

Feb 26, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mikael Lördal, Cheif MD	Department for Gastrointestinal Medicine, Karolinska University Hospital, Huddinge	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department for Gastrointestinal medicin Karolinska University Hospital		Huddinge		141 86	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D003093	Colitis, Ulcerative
D010349	Patient Compliance

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided