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    Summary
    EudraCT Number:2007-004895-37
    Sponsor's Protocol Code Number:SPD476-313
    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:2007-12-17
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-004895-37
    A.3Full title of the trial
    A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 versus Placebo over 104 weeks in the Prevention of Recurrence of Diverticulitis.
    A.4.1Sponsor's protocol code numberSPD476-313
    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 Pharmaceutical Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 Yes
    D.2.1.1.1Trade name Mezavant LP
    D.2.1.1.2Name of the Marketing Authorisation holderShire Pharmaceutical Contracts Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.2Product code SPD476
    D.3.4Pharmaceutical form Film-coated 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.3.10 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.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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diverticulitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10013538
    E.1.2Term Diverticulitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the proportion of subjects without recurrence of diverticulitis between 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD at Week 104. Recurrence of diverticulitis is defined as:
    • Presence of each and all of the following three items:
    1. Abdominal pain
    2. A 15% increase in white blood cell (WBC) count from baseline and a shift to the left (1% increase in bands)
    3. Bowel wall thickening (>5mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan
    OR
    • Surgical intervention for diverticular disease
    E.2.2Secondary objectives of the trial
    • Time to recurrence of diverticulitis & presence of abdominal pain
    • Time to a 15% increase in WBC count from baseline and a shift to the left (1% increase in bands)
    • To compare the proportion of subjects without recurrence of diverticulitis between 3 doses of SPD476 and placebo QD at Weeks 26 & 52
    • To compare the proportion of subjects with recurrence of complicated versus uncomplicated diverticulitis between 3 doses of SPD476 and placebo
    • To compare the change in C-Reactive Protein (CRP) from Baseline at all study visits between treatment groups
    • To compare the proportion of subjects requiring surgical intervention for diverticular disease up to 104 weeks post baseline between 3 doses of SPD476 and placebo QD
    • To compare Quality of Life using the EQ5D and Health Utilities Index
    questionnaires between treatment groups at Baseline, Weeks 16, 52 & 104
    • To assess the safety and tolerability of 3 doses of SPD476 over 104 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for inclusion, each subject must meet each of the following criteria at screening, and must continue to fulfil these criteria at baseline:
    1. Written, signed, and dated informed consent to participate in the study must be given by the subject, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures listed in Section 6.2.
    2. Male and female subjects ³18 years of age
    3. Males, or non-pregnant, non-lactating females of childbearing potential (FOCP), as demonstrated by negative beta HCG (human chorionic gonadotropin) serum pregnancy test, who agree to comply with any applicable contraceptive requirements of the protocol (refer to Section 4.4)
    4. At least one documented attack of acute diverticulitis in the previous 24 months that has clinically resolved without colonic resection. (Documentation must include: physical examination, laboratory analysis, and a verifiable report confirming acute diverticulitis by CT scan, MRI scan, or endoscopy.)
    5. Flexible sigmoidoscopy confirmation of diverticulosis with at least three diverticula noted. Frank ulceration and evidence of ischaemia is not acceptable. The presence of mild erythema and loss of vascularity (oedema) is not exclusionary
    6. WBC count within normal reference ranges
    7. Polymorphonuclear leukocyte [PMN] level within normal reference ranges
    8. Subject and Investigator must agree that participation in this study is in the best interest of the subject
    E.4Principal exclusion criteria
    Subjects are excluded from the study if any of the following criteria are met at screening or at baseline:
    1. History of complicated diverticular disease (peritoneal abscesses, surgical resection for diverticular stricture, active fistula disease), history of diverticular bleed or colonic stricture
    2. Clinically relevant gross extraluminal pathology as shown by CT scan
    3. Right sided diverticulosis only
    4. Abdominal pain and abdominal tenderness upon palpation
    5. Active peptic ulcer disease
    6. History of or current presence of inflammatory bowel disease (IBD) or documented history of irritable bowel syndrome requiring regular monthly medication
    7. Active GI bleeding, except for positive faecal occult blood test (FOBT) in the stool
    8. Allergy or hypersensitivity to mesalazine (5-ASA) or aspirin
    9. Subjects with asthma are excluded only if they are known to be mesalazine-sensitive
    10. Allergy to radiologic contrast agents
    11. Subjects must not have used another Investigational product within 30 days prior to Baseline
    12. Use of antibiotic therapy within 4 weeks of Baseline
    13. Use of prebiotic medication, or probiotic medication, as well as tegaserod, alosetron, laxatives, metaclopramide, domperidone, anti-spasmotic agents, and anti-diarrhoeal agents within 14 days of Baseline
    14. Use of biologics (anti-TNF agents)
    15. Use of immunomodulators (e.g., azathioprine, 6-mercaptopurine) within 6 weeks prior to Baseline
    16. Use of systemic or rectal steroids within 6 weeks of Baseline
    17. Subjects using any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, COX-2 inhibitors, or ibuprofen on a regular basis (defined as over-the-counter NSAID use for 3 consecutive days or 7 occurrences per month, with the exception of aspirin [£325mg/day] taken for cardiac prophylaxis)
    18. Subjects with clinically relevant moderate or severe renal or hepatic impairment are contraindicated with mesalazine products
    19. Previous colorectal surgery (with the exception of haemorrhoidectomy, colonic removal of benign polyps, and appendectomy)
    20. Current or relevant previous disease that could affect the colon, action, absorption, or disposition of the investigational product, or clinical or laboratory assessments
    21. Malignancy, except for basal cell skin cancer, cervical carcinoma in-situ, or carcinoma in-situ in a colonoscopically removed polyp
    22. Subjects with a history of alcohol or other substance abuse within the previous year
    23. Current or relevant history of serious, severe, or unstable (acute of progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures
    24. Subjects who have previously been screened for or enrolled into this study and subsequently withdrawn
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is the proportion of subjects without a recurrence of diverticulitis at Week 104. Recurrence of diverticulitis is defined as:
    • Presence of each and all of the following three items:
    1. Abdominal pain
    2. A 15% increase in white blood cell count (WBC) from baseline and a shift to the left (1% increase in bands)
    3. Bowel wall thickening and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan
    OR
    • Surgical intervention for diverticular disease

    The secondary efficacy variables are:
    • Time to recurrence of diverticulitis
    • Time to presence of abdominal pain
    • Time to a 15% increase in white blood cell count (WBC) from baseline and a shift to the left (1% increase in bands)
    • To compare the proportion of subjects without recurrence of diverticulitis between 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD at Weeks 26 and 52
    • To compare the severity of recurrence of diverticulitis (complicated versus uncomplicated) between 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD
    • To compare the change in CRP from Baseline at all study visits between treatment groups
    • To compare the proportion of subjects requiring surgical intervention for diverticular disease up to 104 weeks post baseline
    • To compare QoL using the EQ5D and HUI questionnaires between treatment groups at Baseline, Weeks 16, 52, and 104
    • To assess the safety and tolerability of SPD476 1.2g/day QD, 2.4g/day QD, and 4.8g/day QD over 104 weeks

    Tertiary Outcomes
    The tertiary efficacy variables are:
    • To compare flexible sigmoidoscopy assessments between treatment groups at Screening and End of Study visits
    • To compare histology of biopsy samples between treatment groups at Screening and End of Study visits
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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.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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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 Information not present in EudraCT
    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 years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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 Information not present in EudraCT
    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 2007-12-17. 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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 163
    F.4.2.2In the whole clinical trial 584
    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 Decision2008-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-03-05
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    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
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