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    Summary
    EudraCT Number:2006-005526-23
    Sponsor's Protocol Code Number:NSP/0002/07
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-04-27
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2006-005526-23
    A.3Full title of the trial
    Randomised controlled trial of soluble plantain fibre for maintenance of health during periods of remission in Crohn's disease v2
    A.3.2Name or abbreviated title of the trial where available
    Plantain NSP in Crohn's disease
    A.4.1Sponsor's protocol code numberNSP/0002/07
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN62819212
    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 SponsorProvexis Plc
    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 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 namePlantain NSP
    D.3.2Product code NSP001
    D.3.4Pharmaceutical form Powder for oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typefood ingredient derived from plantain (musa spp)
    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 placeboPowder for oral solution
    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
    Crohn's Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To examine the efficacy of the soluble plantain fibre, incorporated into an FSMP prototype and given as a supplement to the normal diet. We are principally concerned with the ability of soluble plantain fibre to maintain health during remission in Crohn’s disease patients. This will be determined using the Crohn’s disease activity index (CDAI) with an increase of 100 points above baseline levels indicating that the patient has relapsed. Relapse of Crohn’s disease, defined as an increase in CDAI >100 above baseline or the initiation of corticosteroids or an anti-metabolite (azathioprine, 6-mercaptopurine or methotrexate), or infliximab or adilumimab or enteral nutrition or any of these in combination for the treatment of symptoms of Crohn’s disease.
    E.2.2Secondary objectives of the trial
    Time to first relapse (days) Relapse, defined as a rise in CDAI>150 Rise in serum CRP concentration of 10mg/l above baseline Deterioration in quality of life score, as measured by disease-specific HRQoL instrument (the UK version of the Inflammatory Bowel Disease Questionnaire) and by a multi-attribute generic measure of utility (EuroQol, EQ5D) Deterioration in patient’s global assessment of disease activity as determined by visual analogue scores The need for hospitalization and/or surgery The direct medical costs from the perspective of the UK NHS Acceptability of supplement as determined by visual-analogue scores Impact on faecal constituents, to include measuring transient or permanent alterations in bacterial populations, changes in short chain fatty acid production, and changes in faecal water toxicity
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudy 1: Biopsy study v1_22 October 2007. The main objective is to test the hypothesis that soluble plantain fibre prevents adherence of biopsy-associated E. coli. The biopsy study will involve patients undergoing two additional flexible sigmoidoscopies at each of which four small (≤5mm) mucosal biopsies will be taken using standard diagnostic endoscopic forceps. Biopsies will be taken once before the study commences, at 3 months after the start of the trial and for patients who relapse, an additional set of biopsies will be taken at the time of withdrawal. Biopsies will be studied for the presence of tissue-associated E. coli using a bacterial culture system (the gentamicin protection assay). Bacterial DNA will also be extracted from biopy tissue and will be used to to quantify and characterise the biopsy-associated microbiota. The biopsy study will be offered to patients on a voluntary basis. The primary objective of the biopsy study is the quantification of biopsy-associated E. coli. We are also interested to determine the impact of the plantain fibre on the biopsy-associated microbiota.
    E.3Principal inclusion criteria
    (i) Patients with Crohn’s disease as diagnosed by conventional clinical, radiological and histological criteria. (ii) Crohn’s disease involving small bowel, colon or both. (iii) Crohn’s disease that is in remission: Crohn’s Disease Activity Index (CDAI) < 150 (iv) Patients who have had a relapse of disease within the previous 12 months (Harvey Bradshaw Index modified for retrospective use).
    E.4Principal exclusion criteria
    (i) Patients under 18 or unable to give informed consent. (ii) Patients who have had surgery for Crohn’s disease within the previous 12 months. (iii) Any change to medication for Crohn’s disease within the previous 3 months. (iv) Patients receiving corticosteroids or infliximab or anti-TNFs within the previous 3 months. (v) CDAI >150 (viii) Patients currently receiving enteral nutrition as part of their treatment for Crohn’s disease. (viii) Participation in other trials in the last 3 months.
    E.5 End points
    E.5.1Primary end point(s)
    Relapse of Crohn’s disease, defined as an increase in CDAI >100 above baseline or the initiation of corticosteroids or an anti-metabolite (azathioprine, 6-mercaptopurine or methotrexate), or infliximab or adalimumab or enteral nutrition or any of these in combination for the treatment of symptoms of Crohn’s 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 No
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned4
    E.8.5The trial involves multiple Member States No
    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 Yes
    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 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 years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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) No
    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 2009-04-27. 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 state76
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Expected normal treatment for the condition
    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 Decision2009-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-02-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-11-18
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