Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44383   clinical trials with a EudraCT protocol, of which   7396   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Adherence of a 1.600 mg single tablet 5-ASA treatment of Ulcerative colitis (EASI-trial)

    Summary
    EudraCT number
    		 2019-002070-31
    Trial protocol
    		 DK  
    Global end of trial date
    07 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2026
    First version publication date
    13 Mar 2026
    Other versions
    Summary report(s)
    		 Summary from medical journal

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1337-EASI-trial
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Copenhagen University Hospital hvidovre
    Sponsor organisation address
    Kettegård alle 30, Hvidovre, Denmark,
    Public contact
    The Gastro Unit, medical section, Copenhagen University Hospital Hvidovre, gastroenhed.hvidovrehospital@regionh.dk
    Scientific contact
    The Gastro Unit, medical section, Copenhagen University Hospital Hvidovre, gastroenhed.hvidovrehospital@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 May 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jan 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate whether a simplified treatment regimen for Mesalazine (5- ASA) (1600 mg as one tablet per day [intervention]) improves adherence compared to conventional therapy.
    Protection of trial subjects
    No specific were put in place
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 178
    Worldwide total number of subjects
    178
    EEA total number of subjects
    178
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    165
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This was an open-label randomised controlled phase IV trial including 190 patients with ulcerative colitis in remission. Patients were recruited from November 2019 to March 2024 through the outpatient clinic at the Gastrounit, Medical Division at Copenhagen University Hospital—Amager and Hvidovre.

    Pre-assignment
    Screening details
    		 Patients had to have an age between 18 and 70 years, inclusive, at the time of inclusion. Additionally, patients had to be in stable remission on 5-ASA (defined as partial Mayo score ≤ 1) for at least 2 months and have endoscopic remission (Mayo Clinic Endoscopic Score ≤ 1) if inclusion endoscopy was performed. Patients were excluded from the

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 1600 mg ASACOL arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ASACOL 1600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Gastroenteral use
    Dosage and administration details
    1 tablet of 1600 mg ASACOL once daily

    Arm title
    		 2400 mg ARM
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    2400 mg ASACOL
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Gastroenteral use
    Dosage and administration details
    3, 800 mg ASACOL tablet once daily

    Number of subjects in period 1
    		1600 mg ASACOL arm 2400 mg ARM
    Started
    89
    89
    Completed
    79
    79
    Not completed
    10
    10
         Lack of time
    3
    2
         Consent withdrawn by subject
    -
    3
         Adverse event, non-fatal
    2
    -
         Lack of efficacy
    5
    5

    Baseline characteristics

    		 Close Top of page

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    1600 mg ASACOL arm
    Reporting group description
    		 -

    Reporting group title
    2400 mg ARM
    Reporting group description
    		 -

    Primary: Medical adherence

    		 Close Top of page
    End point title
    		 Medical adherence
    End point description
    medical adherence as measured by MARS-5 score and through drug accountability log
    End point type
    Primary
    End point timeframe
    1 year
    End point values
    		 1600 mg ASACOL arm 2400 mg ARM
    Number of subjects analysed
    89
    89
    Units: s
        number (not applicable)
    82
    78
    Statistical analysis title
    		 Adherence >= 80 %
    Comparison groups
    1600 mg ASACOL arm v 2400 mg ARM
    Number of subjects included in analysis
    178
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.32 [1]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [1] - non-significant

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    November 2019 to January 2025
    Adverse event reporting additional description
    None related to the IMP
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    1600 mg arm
    Reporting group description
    		 -

    Reporting group title
    2400 mg arm
    Reporting group description
    		 -

    Serious adverse events
    		 1600 mg arm 2400 mg arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 89 (14.61%)
    5 / 89 (5.62%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck discomfort
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Lymphangitis
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Emergency cesarean section
         subjects affected / exposed
    2 / 89 (2.25%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AV nodal tachycardia
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NSTEMI
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Laryngitis
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicectomy
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erysipelas
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Meningitis
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalemia
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 1600 mg arm 2400 mg arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 89 (20.22%)
    13 / 89 (14.61%)
    Injury, poisoning and procedural complications
    Subluxation shoulder
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Broken bones
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    0
    1
    Tendon injury
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    0
    1
    Cardiac disorders
    Heart pounding
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Heart rate high
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Chest ache
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    0
    1
    Palpitations
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    0
    1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Facial paraesthesia
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Tension headache (excl migraine)
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Otitis media
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Left otitis externa
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 89 (2.25%)
    0 / 89 (0.00%)
         occurrences all number
    2
    0
    Nausea and vomiting symptoms
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Fissure in ano
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Menopausal menorrhagia
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Polyp of cervix
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Primary sclerosing cholangitis
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Gallstone attack
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Haematoma
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Papule
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Recurrent UTI
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    0
    2
    Incontinence of urine
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    0
    1
    Kidney stones
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0
    Polyarthritis
         subjects affected / exposed
    0 / 89 (0.00%)
    1 / 89 (1.12%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Iron deficiency
         subjects affected / exposed
    1 / 89 (1.12%)
    0 / 89 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Oct 2022
    Redefinition of inclusion criteria allowing ommition of Sigmoidoscopy

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Mar 14 22:23:58 CET 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA