Crohn's DiseaseNCT00917514
An Investigational Study to Test Usability of the Electronic Dosing Equipment Medicpen
An observational study of Crohn's Disease and Ulcerative Colitis, run by Medicpen AB at 1 site in Sweden.
Trial summary
This is a study of the electronical dosing tool MedicPen and it's qualities with regards to user friendliness and medication compliance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2009to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- Patients who are, for some reason, judged by the responsible investigator to be unable to handle the device to be tested.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department for Gastrointestinal medicin Karolinska University Hospital
Huddinge, 141 86
About this study
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
This is a study of the electronical dosing tool MedicPen and it's qualities with regards to user friendliness and medication compliance.
Read the 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.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Dosing Tool, Compliance, User Friendly, Crohn's Disease, Ulcerative Colitis
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Patient Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
User friendliness of Dosing Tool MedicPen
Measured: June 2009 to Nov 2009
Secondary outcomes (1)
Measure treatment compliance
Measured: June 2009 to Nov 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicpen AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mikael Lördal, Cheif MD, Principal investigator, Department for Gastrointestinal Medicine, Karolinska University Hospital, Huddinge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917514
- Sponsor's protocol ID
- MP-01
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2009
- Last updated
- 26 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00917514
- Acronym / sponsor ID
- MP-01
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- Dosing Tool, Compliance, User Friendly, Crohn's Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medicpen ABIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who are, for some reason, judged by the responsible investigator to be unable to handle the device to be tested.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
User friendliness of Dosing Tool MedicPen
Time frame: June 2009 to Nov 2009
1 secondary outcome
Measure treatment compliance
Time frame: June 2009 to Nov 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2010.
- Homepage of sponsorLink provided by the sponsor.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikael Lördal, Cheif MD principal investigator
Department for Gastrointestinal Medicine, Karolinska University Hospital, Huddinge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by Medicpen AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
User friendliness of Dosing Tool MedicPen (time frame: June 2009 to Nov 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2010.