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Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04133194
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Flemming Bendtsen, Copenhagen University Hospital, Hvidovre

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Mesalazine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial)
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1600 mg Asacol (mesalazine)
1600 mg mesalazine (Asacol) treatment regimen (1 tablet per day) for a year
Drug: Mesalazine
1600 mg Asacol [mesalazine]

Active Comparator: 800 mg Asacol (mesalazine)
800 mg mesalazine (Asacol) treatment regimen (3 tablets per day) for a year
Drug: Mesalazine
800 mg Asacol [mesalazine]




Primary Outcome Measures :
  1. 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


  2. 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.


  3. 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



Secondary Outcome Measures :
  1. Assessment of disease activity by Mayo Score [ Time Frame: through study completion, an average of 2 year ]
    The Mayo Score is composed of 4 items. A score from 0-2 is categorised as remission and 11-12 as severe.

  2. Assessment of disease activity by the Simple clinical colitis activity index (SCCAI) [ Time Frame: through study completion, an average of 2 year ]
    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.

  3. Assessment of endoscopic severity by the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) [ Time Frame: through study completion, an average of 2 year ]
    The UCEIS endoscopic severity on a scale of 1-4. Higher score mean worse disease severity.

  4. Assessment of endoscopic severity by the Mayo endoscopic score [ Time Frame: through study completion, an average of 2 year ]
    The Mayo endoscopic score is scored on a scale of 0-3. Higher score mean worse disease severity.

  5. Assessment of histological severity by the Geboes score [ Time Frame: through study completion, an average of 2 year ]
    The Geboes score is interpreted as such: a higher score means higher disease activity.

  6. Assessment of histological severity by the Nancy Index [ Time Frame: through study completion, an average of 2 year ]
    The Nancy Index are interpreted as such: The grade 4 correspond to severe disease, grade 0 as " absence of significant histological disease".

  7. Assessment of histological severity by the Robarts Histopathology Index (RHI) [ Time Frame: through study completion, an average of 2 year ]
    The RHI are interpreted as such: The score are ranging between 0 (no disease activity) to 33 (severe disease activity).

  8. Correlation between the different clinical scores [ Time Frame: through study completion, an average of 2 year ]

    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).


  9. Remission - days [ Time Frame: through study completion, an average of 2 year ]
    Differences in number of days in remission during the trial

  10. Relapse - days [ Time Frame: through study completion, an average of 2 year ]
    Differences in number of days in relapse during the trial

  11. Remission and relapse - episodes [ Time Frame: through study completion, an average of 2 year ]
    Differences episodes of relapses during the trial

  12. Changes in quality of life [ Time Frame: through study completion, an average of 2 year ]

    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.


  13. Changes in disease specific quality of life [ Time Frame: through study completion, an average of 2 year ]

    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.


  14. Changes in disability among ulcerative colitis patients [ Time Frame: through study completion, an average of 2 year ]

    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.


  15. Changes in sleep quality [ Time Frame: through study completion, an average of 2 year ]

    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.


  16. Changes in resilience [ Time Frame: through study completion, an average of 2 year ]

    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.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

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): NCT04133194


Contacts
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Contact: Flemming Bendtsen, MDSci +45 38623273 Flemming.Bendtsen@regionh.dk
Contact: Bobby Lo, MD bobby.lo@regionh.dk

Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Investigators
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Principal Investigator: Flemming Bendtsen, MDSci Copenhagen University Hospital, Hvidovre

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Responsible Party: Flemming Bendtsen, Professor, Senior doctor, MDSci, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT04133194    
Other Study ID Numbers: 1337-EASI-trial
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents