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    Summary
    EudraCT Number:2007-004896-20
    Sponsor's Protocol Code Number:SPD476-314
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-02-23
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2007-004896-20
    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 numberSPD476-314
    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 XL
    D.2.1.1.2Name of the Marketing Authorisation holderShire Pharmaceutical Contracts Ltd
    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.3.2Product 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.3.9.1CAS number 89576
    D.3.9.2Current sponsor codeSPD476
    D.3.9.3Other descriptive nameMezavant
    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 time to recurrence of diverticulitis between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD in subjects who have had at least one previous attack of diverticulitis.
    Recurrence of diverticulitis is defined as:
    • A positive spiral computerised axial tomography (CT) scan for diverticulitis as evidenced by, at a minimum, fat stranding (with or without bowel wall thickening >5mm)
    OR
    • Surgical intervention for diverticular disease
    E.2.2Secondary objectives of the trial
    • To compare the proportion of subjects without recurrence of diverticulitis between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD at weeks 26, 52, and 104
    • To compare the proportion of subjects with recurrence of complicated versus uncomplicated diverticulitis between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD
    • To compare the proportion of subjects requiring surgical intervention for diverticular disease between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD
    • To compare Quality of Life (QoL) using the EQ5D and Health Utilities Index (HUI2) questionnaires between treatment groups at Baseline, Weeks 16, 52, 78, and 104 between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD
    • To assess the safety and tolerability of SPD476 1.2g/day QD, 2.4g/day QD, and 4.8g/day QD for the duration of the treatment period
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Study Title: A follow-on, prospective outcomes sub-study to summarise healthcare resource utilisation and quality of life in subjects who withdraw study medication due to diverticulitis from SPD476-314, version 2 - 16 May 2008

    Primary:
    To summarise healthcare resource utilisation in subjects who withdraw due to diverticulitis from the SPD476-314 study.
    Recurrence of diverticulitis is defined as:
    • A positive spiral computerised axial tomography (CT) scan for diverticulitis as evidenced by, at a minimum, fat stranding (with or without bowel wall thickening >5mm)
    OR
    • Surgical intervention for diverticulitis disease
    Secondary:
    • To summarise quality of life in subjects who withdraw due to recurrence of diverticulitis
    E.3Principal inclusion criteria
    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
    2. Male and female subjects ≥18 years of age
    3. If female of childbearing potential (FOCP), has demonstrated a negative beta HCG (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any applicable contraceptive requirements of the protocol
    4. At least one documented attack of acute diverticulitis in the previous 24 months that has clinically resolved without colonic resection. Documentation must include a verifiable report confirming acute diverticulitis (examples include CT scan, magnetic resonance imaging (MRI) scan, ultrasound, endoscopy of the sigmoid colon, or barium enema)
    5. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon, with at least three diverticula noted. The presence of mild erythema and loss of vascularity (oedema) is acceptable, whereas frank ulceration and evidence of ischaemia is not
    6. White blood cell (WBC) count within central laboratory normal reference ranges
    7. Polymorphonuclear leukocyte (PMN) level within central laboratory 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
    1. Subjects who have had an attack of diverticulitis and/or continue to exhibit signs and symptoms of diverticulitis within 6 weeks prior to and up to Baseline
    2. Previous colorectal surgery, including surgical intervention for diverticular disease, (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)
    3. Clinically relevant gross extraluminal pathology as shown by CT scan
    4. Right sided diverticulosis only
    5. Active peptic ulcer disease
    6. History of or current presence of inflammatory bowel disease (IBD)
    7. Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication
    8. Active GI bleeding, except for positive faecal occult blood test (FOBT) in the stool
    9. Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline
    10. Allergy or hypersensitivity to mesalazine (5-ASA) or aspirin
    11. Subjects who are unwilling or unable to undergo a CT scan or have a known or suspected allergy to all radiologic contrast agents
    12. Subjects must not have used another investigational product within 30 days prior to Baseline
    13. Within 14 days of Baseline, use of prebiotic, probiotic, or 5-ASA medications, as well as drugs active at the 5HT-receptor (e.g., tegaserod, alosetron, metaclopramide), or anti-spasmotic agents
    14. Any current or historical 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. Use of inhaled or nasal steroids is acceptable
    17. Subjects who have conditions requiring regular and ongoing use of anti-inflammatory drugs, including NSAIDs, such as aspirin, COX-2 inhibitors, or ibuprofen. Use of aspirin (≤325mg/day) taken for cardiac prophylaxis is acceptable
    18. Subjects with clinically relevant moderate or severe renal or hepatic impairment are contraindicated with mesalazine products
    19. Current or relevant previous disease that could affect the colon, action, absorption, or disposition of the investigational product, or clinical or laboratory assessments
    20. Any history of malignancy, except for basal cell skin cancer, cervical carcinoma in-situ, or carcinoma insitu in a colonoscopically removed polyp
    21. Subjects with a history of alcohol or other substance abuse within the previous year
    22. Females who are lactating
    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)
    Primary:
    To compare the time to recurrence of diverticulitis between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD in subjects who have had at least one previous attack of diverticulitis

    Recurrence of diverticulitis is defined as:
    • A positive spiral computerised axial tomography (CT) scan for diverticulitis as evidenced by, at a minimum, fat stranding (with or without bowel wall thickening >5mm)
    OR
    • Surgical intervention for diverticular disease.

    Secondary:
    • To compare the proportion of subjects without recurrence of diverticulitis between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD at Weeks 26, 52, and 104
    • To compare the proportion of subjects with recurrence of complicated versus uncomplicated diverticulitis between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD
    • To compare the proportion of subjects requiring surgical intervention for diverticular disease between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD
    • To compare Quality of Life (QoL) using the EQ5D and Health Utilities Index (HUI2) questionnaires between treatment groups at Baseline, Weeks 16, 52, 78, and 104 between each of 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD
    • To assess the safety and tolerability of SPD476 1.2g/day QD, 2.4g/day QD, and 4.8g/day QD for the duration of the treatment period.

    Tertiary:
    • To compare lower endoscopy assessments of the sigmoid area between treatment groups at Screening and Week 104 and/or Withdrawal of Treatment visits
    • To compare histology of biopsy samples between treatment groups at Screening and Week 104 and/or Withdrawal of Treatment visits.
    • To compare the change in WBC count from Baseline between treatment groups at all study visits
    • To compare the proportion of subjects with a shift to the left (1% increase in bands) between treatment groups at all study visits
    • To compare the change in C-Reactive Protein (CRP) from Baseline between treatment groups at all study visits.
    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 Yes
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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 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 2009-02-23. 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 state75
    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 Decision2009-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-28
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