Ulcerative ColitisPhase 4EASINCT04133194
Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis
A Phase 4 study testing Mesalazine in people with Ulcerative Colitis, run by Flemming Bendtsen at 1 site in Denmark.
Trial summary
Several oral mesalazine (5-ASA) formulations exist, but the regimes require several tablets per day. Such regimens are not ideal and can interfere with normal daily activities of patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Mesalazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Nov 2019to 1 Mar 2025
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent
- Age between and including 18 and 60
- Diagnosed with UC according to the Copenhagen Diagnostic Criteria
- Length of disease of max. 10 years
- Stable remission on 5-ASA (defined as partial Mayo score ≤1) for at least 2 months without need for oral corticosteroids before inclusion.
- Endoscopic remission defined as Mayo Clinic Endoscopic Score < 2
- Have had a relapse within the last 2 years
- Defined as the need of escalation of treatment or change medical treatment.
Who cannot join
- Evidence of infectious diarrhoea (i.e. pathogenic viruses, bacteria or Clostridium difficile toxin in stool culture) within the last month
- On immunomodulators, including methotrexate
- On any biological therapy
- Any previous abdominal surgery related to UC
- Any chronic infections (e.g. HBV, HCV, HIV)
- Any severe concomitant cardiovascular, autoimmune, hematologic, hepatic, renal, endocrine, oncologic or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results
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- Well-founded doubt about the patient's cooperation, e.g., because of addiction to alcohol or drugs in the opinion of the investigators.
- Participation in another clinical trial within the last 30 days, or simultaneous participation in another clinical trial.
- Any previous documented allergic reaction to tested the medical drugs
Trial locations and contacts
1 site in 1 country.
Bobby Lo, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital Hvidovre
Hvidovre, 2200
Flemming Bendtsen, Flemming.bendtsen@regionh.dk
Bobby Lo, +4528580410, bobby.lo@regionh.dk
About this study
Official title: Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial)
Several oral mesalazine (5-ASA) formulations exist, but the regimes require several tablets per day. Such regimens are not ideal and can interfere with normal daily activities of patients. Non-adherence has been associated with an increase in the risk of relapse and worse disease course; leading to a decrease in quality of life, an increase in societal and personal costs, and worst case increases the risk of colorectal cancer. Recently, a new formula for 5-ASA has been approved by the Danish Medicine Agency, with a single tablet regime per day.
Primary purpose:
Read more
- To investigate whether a simplified treatment regimen for 5- ASA (1600 mg as one tablet per day [intervention]) improves adherence with preserved remission rates compared to conventional therapy.
Secondary purposes:
- Compare levels of endoscopic, mucosal and histological inflammation in predicting risk of relapse between the intervention group and the conventional therapy group.
- Investigate whether a simplified treatment regimen improves the disease course compared to the conventional therapy.
- To assess the correlation between different endpoints and the disease courses, with the use of clinical, endoscopic, histological, self-reported and biochemical markers.
- Improve, correlate and assess patient-reported outcomes in a prospective manner.
- To establish a biobank of cases with quiescent/mild ulcerative colitis (UC) for identification of future biomarkers.
- Conditions
- Ulcerative Colitis
- Being tested
- Mesalazine
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesalazineDrug
1600 mg Asacol [mesalazine]
MesalazineDrug
800 mg Asacol [mesalazine]
| Study group | Role | What they receive |
|---|---|---|
| 1600 mg Asacol (mesalazine) | Experimental | 1600 mg mesalazine (Asacol) treatment regimen (1 tablet per day) for a year Receives: Drug: Mesalazine |
| 800 mg Asacol (mesalazine) | Active comparator | 800 mg mesalazine (Asacol) treatment regimen (3 tablets per day) for a year Receives: Drug: Mesalazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Adherence
Measured by drug accountability log
Patients having taken ≥80 % are categorised as adherent
Measured: through study completion, an average of 2 year
Medical Adherence
Measured by "Medical adherence rating scale" (MARS)
Medical adherence rating scale is a self-reported medical adherence tool consisting of 5 items scored on a 5 point Likert scale (ranging from 5-25). The scale has been used in several IBD studies and a global score > 20 indicates a good adherence.
Measured: through study completion, an average of 2 year
Medical Adherence
Measured byf drug accountability log (outcome 1) and "Medical adherence rating scale" (MARS, outcome 2) separately, excl. pregnant and breastfeeding women.
Further detail see outcome 1 and 2
Measured: through study completion, an average of 2 year
Secondary outcomes (16)
Assessment of disease activity by Mayo Score
The Mayo Score is composed of 4 items. A score from 0-2 is categorised as remission and 11-12 as severe.
Measured: through study completion, an average of 2 year
Assessment of disease activity by the Simple clinical colitis activity index (SCCAI)
The SCCAI rely solely on clinical assessments. Clinical remission are defined as SCCAI < 1 and clinical response as a change of at least 1 point.
Measured: through study completion, an average of 2 year
Assessment of endoscopic severity by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)
The UCEIS endoscopic severity on a scale of 1-4. Higher score mean worse disease severity.
Measured: through study completion, an average of 2 year
Assessment of endoscopic severity by the Mayo endoscopic score
The Mayo endoscopic score is scored on a scale of 0-3. Higher score mean worse disease severity.
Measured: through study completion, an average of 2 year
Assessment of histological severity by the Geboes score
The Geboes score is interpreted as such: a higher score means higher disease activity.
Measured: through study completion, an average of 2 year
Assessment of histological severity by the Nancy Index
The Nancy Index are interpreted as such: The grade 4 correspond to severe disease, grade 0 as " absence of significant histological disease".
Measured: through study completion, an average of 2 year
Assessment of histological severity by the Robarts Histopathology Index (RHI)
The RHI are interpreted as such: The score are ranging between 0 (no disease activity) to 33 (severe disease activity).
Measured: through study completion, an average of 2 year
Correlation between the different clinical scores
Comparison, correlation and association between the different endoscopic, histological and disease activity indices.
Included will be:
Mayo score, Simple clinical colitis activity index (SCCAI), Ulcerative Colitis Endoscopic Index of Severity (UCEIS), Nancy Index, Robarts Histopathology Index (RHI) and the Geboes score (see outcome 4-10).
Measured: through study completion, an average of 2 year
Remission - days
Differences in number of days in remission during the trial
Measured: through study completion, an average of 2 year
Relapse - days
Differences in number of days in relapse during the trial
Measured: through study completion, an average of 2 year
Remission and relapse - episodes
Differences episodes of relapses during the trial
Measured: through study completion, an average of 2 year
Changes in quality of life
Prospective analyses of quality of life using 12-Item Short Form Survey (SF12).
The SF12 is measured on a global score from 12-56. Beside a global score, a mental and physical dimension will also be calculated.
Measured: through study completion, an average of 2 year
Changes in disease specific quality of life
Prospective analyses quality of life using the Short inflammatory bowel disease questionnaire (SIBDQ)
The SIBDQ is a quality of life (QOL) questionnaire ranging from 10-70. Higher score means better QOL.
Measured: through study completion, an average of 2 year
Changes in disability among ulcerative colitis patients
Prospective analyses of disability using the Inflammatory bowel disease disability index (IBD-DI)
The IBD-DI measures the disability among patients with inflammatory bowel disease. Higher scores means worse disability.
Measured: through study completion, an average of 2 year
Changes in sleep quality
Prospective analyses of sleep using the Pittsburgh Sleep Quality Index (PSQI),
The PSQI was designed to measure sleep quality and disturbance. A global score > 5 is considered poor sleep quality.
Measured: through study completion, an average of 2 year
Changes in resilience
Prospective analyses of resilience using the Brief Resilience Scale (BRS)
The BRS is designed to measure the ability to bounce back or recover from stressful events. Higher scores means higher resilience.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start28 Nov 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flemming Bendtsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Flemming Bendtsen, Copenhagen University Hospital, Hvidovre
- Investigators
- Flemming Bendtsen, MDSci, Principal investigator, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133194
- Sponsor's protocol ID
- 1337-EASI-trial
- Acronym
- EASI
- Status last verified
- Sep 2023
- First submitted
- 10 Oct 2019
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Nordestgaard RLM, Lo B, Bergstrom R, Adzioski I, Skotte H, Hawwa IM, Holme SK, Tiftikci B, Majchrzak K, Vind I, Bendtsen F, Burisch J. Clinical Trial: Evaluating a Single 1600 mg Tablet Regimen of 5-Aminosalicylate for Ulcerative Colitis-The EASI Trial. Aliment Pharmacol Ther. 2025 Nov;62(9):877-886. doi: 10.1111/apt.70375. Epub 2025 Sep 16.
PubMed 40955556
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial)
- ClinicalTrials.gov ID
- NCT04133194
- Acronym / sponsor ID
- EASI / 1337-EASI-trial
- Conditions
- Ulcerative Colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Flemming BendtsenUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 21 Oct 2019 (actual)
- 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.
Several oral mesalazine (5-ASA) formulations exist, but the regimes require several tablets per day. Such regimens are not ideal and can interfere with normal daily activities of patients. Non-adherence has been associated with an increase in the risk of relapse and worse disease course; leading to a decrease in quality of life, an increase in societal and personal costs, and worst case increases the risk of colorectal cancer. Recently, a new formula for 5-ASA has been approved by the Danish Medicine Agency, with a single tablet regime per day.
Primary purpose:
- To investigate whether a simplified treatment regimen for 5- ASA (1600 mg as one tablet per day [intervention]) improves adherence with preserved remission rates compared to conventional therapy.
Secondary purposes:
- Compare levels of endoscopic, mucosal and histological inflammation in predicting risk of relapse between the intervention group and the conventional therapy group.
- Investigate whether a simplified treatment regimen improves the disease course compared to the conventional therapy.
- To assess the correlation between different endpoints and the disease courses, with the use of clinical, endoscopic, histological, self-reported and biochemical markers.
- Improve, correlate and assess patient-reported outcomes in a prospective manner.
- To establish a biobank of cases with quiescent/mild ulcerative colitis (UC) for identification of future biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1600 mg Asacol (mesalazine) | Experimental | Drug: Mesalazine1600 mg mesalazine (Asacol) treatment regimen (1 tablet per day) for a year |
| 800 mg Asacol (mesalazine) | Active comparator | Drug: Mesalazine800 mg mesalazine (Asacol) treatment regimen (3 tablets per day) for a year |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed informed consent
- Age between and including 18 and 60
- Diagnosed with UC according to the Copenhagen Diagnostic Criteria
- Length of disease of max. 10 years
- Stable remission on 5-ASA (defined as partial Mayo score ≤1) for at least 2 months without need for oral corticosteroids before inclusion.
Key exclusion criteria (9 listed)
- Evidence of infectious diarrhoea (i.e. pathogenic viruses, bacteria or Clostridium difficile toxin in stool culture) within the last month
- On immunomodulators, including methotrexate
- On any biological therapy
- Any previous abdominal surgery related to UC
- Any chronic infections (e.g. HBV, HCV, HIV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesalazine1600 mg Asacol [mesalazine] | Drug | 1600 mg Asacol (mesalazine) |
| Mesalazine800 mg Asacol [mesalazine] | Drug | 800 mg Asacol (mesalazine) |
Primary outcome
Medical Adherence
Time frame: through study completion, an average of 2 year
Measured by drug accountability log Patients having taken ≥80 % are categorised as adherent
Medical Adherence
Time frame: through study completion, an average of 2 year
Measured by "Medical adherence rating scale" (MARS) Medical adherence rating scale is a self-reported medical adherence tool consisting of 5 items scored on a 5 point Likert scale (ranging from 5-25). The scale has been used in several IBD studies and a global score > 20 indicates a good adherence.
Medical Adherence
Time frame: through study completion, an average of 2 year
Measured byf drug accountability log (outcome 1) and "Medical adherence rating scale" (MARS, outcome 2) separately, excl. pregnant and breastfeeding women. Further detail see outcome 1 and 2
16 secondary outcomes
Assessment of disease activity by Mayo Score
Time frame: through study completion, an average of 2 year
Assessment of disease activity by the Simple clinical colitis activity index (SCCAI)
Time frame: through study completion, an average of 2 year
Assessment of endoscopic severity by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)
Time frame: through study completion, an average of 2 year
Assessment of endoscopic severity by the Mayo endoscopic score
Time frame: through study completion, an average of 2 year
Assessment of histological severity by the Geboes score
Time frame: through study completion, an average of 2 year
Assessment of histological severity by the Nancy Index
Time frame: through study completion, an average of 2 year
Assessment of histological severity by the Robarts Histopathology Index (RHI)
Time frame: through study completion, an average of 2 year
Correlation between the different clinical scores
Time frame: through study completion, an average of 2 year
Remission - days
Time frame: through study completion, an average of 2 year
Relapse - days
Time frame: through study completion, an average of 2 year
Remission and relapse - episodes
Time frame: through study completion, an average of 2 year
Changes in quality of life
Time frame: through study completion, an average of 2 year
Changes in disease specific quality of life
Time frame: through study completion, an average of 2 year
Changes in disability among ulcerative colitis patients
Time frame: through study completion, an average of 2 year
Changes in sleep quality
Time frame: through study completion, an average of 2 year
Changes in resilience
Time frame: through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 40955556Nordestgaard RLM, Lo B, Bergstrom R, Adzioski I, Skotte H, Hawwa IM, Holme SK, Tiftikci B, Majchrzak K, Vind I, Bendtsen F, Burisch J. Clinical Trial: Evaluating a Single 1600 mg Tablet Regimen of 5-Aminosalicylate for Ulcerative Colitis-The EASI Trial. Aliment Pharmacol Ther. 2025 Nov;62(9):877-886. doi: 10.1111/apt.70375. Epub 2025 Sep 16.
- Individual participant dataSharing planned: Yes
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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.
Bobby Lo, MD contact
Flemming Bendtsen, MDSci principal investigator
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mesalazine in people with Ulcerative Colitis, run by Flemming Bendtsen at 1 site in Denmark.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 26 Sep 2023. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flemming Bendtsen, MDSci (+45 38623273, Flemming.Bendtsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Adherence (time frame: through study completion, an average of 2 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04133194, which also lists 1 linked publication.
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 Sep 2023.