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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
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    The EU Clinical Trials Register currently displays   42572   clinical trials with a EudraCT protocol, of which   7010   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2009-017044-13
    Sponsor's Protocol Code Number:SPD476-409
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-22
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2009-017044-13
    A.3Full title of the trial
    A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate
    the Effect of Remission Status on the Ability to Maintain or Achieve
    Clinical and Endoscopic Remission During a 12-Month, Long-term
    Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine
    Once Daily in Adult Subjects With Ulcerative Colitis
    A.4.1Sponsor's protocol code numberSPD476-409
    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 SponsorShire Development Inc
    B.1.3.4CountryUnited States
    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.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 Yes
    D. name Mezavant XL Gastro-resistant, prolonged release tablets
    D. of the Marketing Authorisation holderShire Pharmaceutical Contracts Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameMezavant XL
    D.3.2Product code SPD476
    D.3.4Pharmaceutical form Gastro-resistant tablet
    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 89-57-6
    D.3.9.2Current sponsor codeSPD476
    D.3.9.3Other descriptive nameMMX Mesalamine/Mesalazine
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.2
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 No
    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
    Ulcerative Colitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to compare the percentage of subjects in complete (clinical and endoscopic) remission after 12 months of maintenance treatment with 2.4g/day MMX mesalamine/mesalazine given once daily (QD) between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment with 4.8g/day MMX mesalamine/mesalazine given QD.
    E.2.2Secondary objectives of the trial
    1. To compare the percentage of subjects in clinical remission at 12 months between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

    2. To compare the time to relapse between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

    3. To compare the percentage of subjects who achieve or maintain mucosal healing (endoscopy score ≤1) at 12 months between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment.

    4. To assess the improvement in symptoms at 3 and 8 weeks of acute treatment.

    5. To assess the percentage of subjects who achieve complete remission at the end of 8 weeks acute treatment.

    6. To assess the safety and tolerability of MMX mesalamine/mesalazine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting all of the criteria listed below at screening may be included in the study:

    1. Adults aged 18 years or older.

    2. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol.

    3. Diagnosis of active mild to moderate UC (acute flare or newly diagnosed with a total score of 4–10 inclusive on the modified UC-DAI with an endoscopy score of ≥1 and a PGA of ≤2)*. The original diagnosis of UC must be established by endoscopy, colonoscopy, or barium enema and have compatible histology.

    4. Stable maintenance therapy of 5-ASA ≤3.2g/day (excluding MMX mesalamine/mesalazine), if 5-ASA is being taken at the onset of acute flare. Stable maintenance therapy is defined as no change in dose, or no initiation of 5-ASA, from the onset of the acute flare through baseline.
    E.4Principal exclusion criteria
    Subjects are excluded from the study if any of the following criteria are met at screening:

    1. Severe UC (assessed by PGA =3).*

    2. Acute flare with onset >6 weeks prior to baseline.

    3. Acute flare while on maintenance MMX mesalamine/mesalazine (LIALDA®, MEZAVANT®, MEZAVANT® XL,MEZAVANT® LP).

    4. Unsuccessfully treated current acute flare using steroids or 5-ASA doses >3.2g/day.

    5. Acute flare on a 5-ASA maintenance therapy of >3.2g/day.

    6. Systemic or rectal steroids use within the 4 weeks prior to screening or immunosuppressants within the last 6 weeks prior to screening.

    7. History of biologic (anti-TNF agent) use.

    8. Antibiotic use or repeated use (>3 consecutive days of use at doses above the prescribed over-the-counter dose) of any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs such as aspirin, COX-2 inhibitors or ibuprofen, within 7 days prior to screening. However, prophylactic use of a stable dose of aspirin up to 325mg/day for cardiac disease is permitted.

    9. Current or recurrent disease, other than UC, that could affect the colon, the action, absorption, or disposition of the investigational medicinal product, or clinical or laboratory assessments.

    * The symptom parameters of the modified UC-DAI (rectal bleeding and stool frequency) will be assessed at screening and baseline, and endoscopy and PGA scores will be obtained at baseline to confirm eligibility.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is to compare the proportion of subjects in complete (clinical and endoscopic) remission after 12 months of maintenance treatment with 2.4g/day MMX mesalamine/mesalazine given QD between subjects who were in complete remission and subjects who were in partial remission at the end of 8 weeks acute treatment with 4.8g/day MMX mesalamine/mesalazine given QD.

    Complete (clinical and endoscopic) remission is defined as a modified UC-DAI ≤1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in
    endoscopy score from baseline (Visit 0).

    Partial remission is defined as a modified UC-DAI ≤3 with a combined stool frequency and rectal bleeding score of ≤1 and not in complete remission.
    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 Yes
    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 Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Last visit of last subject undergoing treatment
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days14
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-06-22. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 225
    F.4.2.2In the whole clinical trial 1000
    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 Decision2010-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-14
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