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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42517   clinical trials with a EudraCT protocol, of which   7000   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:2007-004896-20
    Sponsor's Protocol Code Number:SPD476-314
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-03
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    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.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberSPD476-314
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 Pharmaceuticals 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.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 Information not present in EudraCT
    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.3.4Pharmaceutical 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 mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 Yes
    D. medicinal product typeNon Applicabile
    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
    Confirmed diagnosis of diverticulosis (that has led to uncomplicated 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;Time to 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(1.2g/day QD, 2.4g/day QD,and 4.8g/day QD) and placeboQD at Weeks 26 and 52; 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;the change in C-Reactive Protein-CRP from Baseline at all study visits between treatment groups;the proportion of subjects requiring surgical intervention for diverticular disease up to 104 weeks post baseline between 3 doses of SPD476 (1.2g/day QD, 2.4g/day QD, and 4.8g/day QD) and placebo QD;QoL using the EQ5D and Health Utilities Index quest. between treatment group at Baseline,Weeks16,52and104;To assess the safety and tolerability of SPD476
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    E.3Principal inclusion criteria
    The subject must not be dispensed any study medication before all inclusion criteria (including test results) are confirmed. 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 &#8805;18 years of age 3. Males, or non-pregnant, non-lactating 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 4. At least 1 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 3 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. White blood cell count within normal reference ranges 7. 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
    The subject must not be dispensed any study medication before all exclusion criteria (including test results) are confirmed. 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 [&#8804; 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 colo-rectal 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 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.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. 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 Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    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 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 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 2008-07-03. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state84
    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 Decision2008-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
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