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    Summary
    EudraCT Number:2008-000045-59
    Sponsor's Protocol Code Number:Pentasa FE 999907 CS06
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-08-13
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2008-000045-59
    A.3Full title of the trial
    Multicentre, controlled, randomized, investigator-blinded, comparative study of oral
    Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS
    A.3.2Name or abbreviated title of the trial where available
    MOTUS
    A.4.1Sponsor's protocol code numberPentasa FE 999907 CS06
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFerring SAS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePentasa 2g sachet prolonged release granules (95%)
    D.3.4Pharmaceutical form Granules
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMESALAZINE
    D.3.9.1CAS number 89576
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with mild to moderate ulcerative colitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10058816
    E.1.2Term Colitis ulcerative acute episode
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that mesalazine po 4g per day once daily (QD.) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID.) (2g x 2 per day), in patients with active ulcerative colitis treated for 8 weeks, in terms of remission evaluated with the UC-DAI score and defined as  1. Both groups (4g QD and 2gx2) will receive an enema containing 1g of mesalazine at bedtime during the initial 4 weeks.
    E.2.2Secondary objectives of the trial
    •Compliance
    •Clinical remission at week 4 and week 8
    •Clinical variables improvement (stools frequency and blood stools) at week 4, 8 and 12 separately
    •Treatment failure rates at W4 and W8
    •Time to remission according patient’s diary (normal stools frequency and cessation of bleeding)
    •Time to cessation of bleeding
    •Improvement at week 4 and 8 based on UC-DAI score
    •Endoscopic assessment at W0 and W8
    •Acceptability of the treatment
    •Safety
    •Proportion of patients staying in clinical remission at week 12.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Aged over 18 years.
    •Newly diagnosed or relapsing mild to moderate ulcerative colitis with disease extension beyond rectum (of at least 12-18 cm from the anorectal junction). All patients must have had at least one total colonoscopy in their disease history (within the previous 5 years).
    •Disease activity will be assessed on the 7 days before inclusion and according to ulcerative colitis disease activity index (UC-DAI) score. The UC-DAI score will be from 3 to 8 (mild: 3-5 or moderate: 6-8).
    •Men or non pregnant women.
    •Women with childbearing potential must be using a contraceptive method judged effective by the investigator.
    •Oral maintenance treatment with azathioprine or 6-mercaptopurine (taken for at least 6 months and continued at the same dose throughout the study) is permitted.
    •Informed consent given.
    E.4Principal exclusion criteria
    •Proctitis (less than12-18 cm from the anorectal junction).
    •Previous colonic surgery.
    •Previous failed to respond to steroids within the previous year.
    •Non-response to rectal 5-ASA therapy or to oral 5-ASA therapy at a dose > 3/day for induction of remission within the previous year.
    •Current relapse lasting more than 6 weeks (from what patient says).
    •Severe/fulminant ulcerative colitis.
    •Evidence of other forms of inflammatory bowel disease or infectious disease.
    •Allergy to aspirin or salicylate derivatives.
    •The following treatment will be forbidden during the study (if present at selection, a wash-out will be necessary):
    - Loperamide and other antidiarrheal agents, mucilages, antibiotics (metronidazole
    and ciprofloxacin): 1 week wash-out.
    - Oral steroids: 4 weeks wash-out.
    - Rectal steroids: 2 weeks wash-out
    - Repeated treatment (> 3days of use) of non steroidal anti-inflammatory drugs
    (NSAID) oral or rectal route: 1 week wash-out (aspirin ≤325 mg/day used for
    cardioprotection is allowed).
    - Sulfasalazine > 4g or mesalazine or 4-ASA at a higher dose than what it is
    permitted in the local formulary or standard care for maintenance treatment: 4
    weeks wash-out.
    - Immunomodulating/suppressing drugs: 3 month for wash out (except for
    patients maintained on azathioprine or 6-mercaptopurine -see above).
    •Known significant hepatic or renal function abnormalities.
    •Moderate/severe abnormal renal, hepatic or blood count tests defined as: creatinine plasma value > 1.5 x ULN or white blood cells < 3500/mm3 or > 15000/mm3 or platelets < 100000/mm3 or > 800000/mm3 or ASAT/ALAT > 3 x ULN or GGT/Alkalin Phosphatases > 3x ULN (Primary Sclerosing Cholangitis is not an exclusion criteria),
    •History or physical examination findings indicative of active alcohol or drug abuse,
    •Pregnancy or breast-feeding,
    •History of disease, including mental/emotional disorder, that might interfere with their participation in the study,
    •Participation in another clinical study in the last 3 months.
    •Inability to comply with the protocol requirements.
    •Inability to fill in the diary cards.
    E.5 End points
    E.5.1Primary end point(s)
    •Primary efficacy criterion: remission after 8 weeks of treatment, defined on the basis of the UC-DAI score ≤1.
    •Secondary efficacy variables
    oCompliance at W8
    oClinical remission at week 4, 8 and 12
    oTreatment failure rates at W4 and W8 defined as the need for other treatment than those allowed by the protocol. Treatment failure will be counted as non-remission
    oClinical variables (Stool frequency and bloody stools) at week 4, 8 and 12 separatly
    oTime of cessation of bleeding
    oTime to remission according patient’s diary (normal stools frequency and cessation of bleeding)
    oImprovement at week 4 and week 8 based on UC-DAI score
    oEndoscopic assessment at week 0 and at week 8
    oAcceptability of the treatment at W4 and W8
    oSafety
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    investigator blinded, patient opened
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Same IMP, the comparator is the reference regimen 4g per day in 2 divided doses (BID)
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned40
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days88
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days88
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 398
    F.4.2.2In the whole clinical trial 398
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-16
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