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    Summary
    EudraCT Number:2008-002100-26
    Sponsor's Protocol Code Number:FE 999907 CS05
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-08-18
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2008-002100-26
    A.3Full title of the trial
    PENTASA in active Crohn’s Disease: A 10-week, double-blind, multi-centre trial comparing PENTASA Sachet 6 g/day (mesalazine, mesalamine) with placebo
    A.3.2Name or abbreviated title of the trial where available
    PEACE
    A.4.1Sponsor's protocol code numberFE 999907 CS05
    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 SponsorFerring Pharmaceuticals A/S
    B.1.3.4CountryDenmark
    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 PENTASA Sachet
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Leciva a.s., Czech republic
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 Prolonged-release 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 codeFE999907
    D.3.9.3Other descriptive nameMesalamine, 5-aminosalicylic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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 placeboGranules
    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
    Active mild to moderate crohn's disease.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that a daily dose of 6 g PENTASA Sachet administered as a 2 g morning dose and a 4 g evening dose during a period of 10 weeks is superior to placebo in active mild to moderate CD in terms of response rate (a reduction in Crohn’s Disease Activity Index (CDAI) score to <150 or a decrease in CDAI score of at least 70)
    E.2.2Secondary objectives of the trial
    • Number of patients with sustained remission (defined as a reduction in CDAI score to <150 for at least two weeks)
    • The onset of response (defined as a reduction in CDAI score to <150 or a decrease in CDAI score of at least 70, whichever is first)
    • The onset of a reduction in the CDAI score to <150
    • The onset of a decrease in CDAI score of at least 70
    • The onset of response sustained until Week 10
    • The number of weeks in response
    • Treatment failure
    • Safety
    • Quality of Life (QoL)
    • Work productivity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At Visit 1 (screening visit)
    1.Signed written informed consent obtained before conduction of any trial related procedures
    2.Age ≥18 years
    3.CD symptoms/onset of disease: ≥ 3 months prior Visit 1
    4.Ileal, ileo-colonic or colonic non-stricturing/non-penetrating disease
    5.A confirmed diagnosis and location of CD (by MRI, X-ray (small bowel and/or colon), and/or endoscopy) at any time since the disease was diagnosed
    6.A Harvey-Bradshaw score between 5 and 12
    7.Males and non-pregnant, non-nursing women. Female patients should be post menopausal (women ≥ 45yrs with no menstrual period for at least 12 months without an alternative medical cause), be surgically sterile, or be using medically approved contraception throughout the trial period.
    8.Normal values of proteinuria and leucocyturia (=0/+)

    At Visit 2 (randomisation visit)
    9.Mild to moderate active CD, defined by a CDAI score between 180 and 350
    10.Active inflammatory disease (C-Reactive Protein (CRP) level above or equal to 5 mg/L), or a biopsy verified inflammation, or fecal calprotectin level above or equal to 50 µg/g).
    11.Haemoglobin value above 100 g/L
    12.Values of aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatise (ALP), and/or bilirubin not more than 2 times upper limits of normal (ULN)
    13.Estimated creatinine clearance should be above 75 ml/min.
    E.4Principal exclusion criteria
    At Visit 1 (screening visit)
    1.Any significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or may influence the results of the trial or the patient’s ability to participate in the trial
    2.Ileostomy, ileo-pouch-anal anastomosis, ileorectal anastomosis, subtotal coloectomy and/or proctocoloectomy
    3.Fistulas (external/internal and/or abscess)
    4.Current or previous treatment for stricturing and penetrating disease (current strictures characterised by abdominal pain/cramping with radiologic/MRI/US stenosis with prestenotic dilatation or endoscopic stenosis not passable for the endoscope)
    5.CD located to the upper gastrointestinal tract and/or jejunal part of the small intestine.
    6.CD isolated to colon below the left colon flexure and/or isolated proctitis and/or anal disease
    7.Prior treatment resistance to mesalazine defined as no effect seen by treatment of active Crohn´s disease with ≥ 4g daily for ≥ 4 weeks
    8.Unsuccessful treatment of current relapse (not applicable for newly diagnosed patients)
    9.Hepatic (including sclerosing cholangitis) or renal functioning abnormalities
    10.Documented histological gastrointestinal malignancy or high-grade dysplasia and/or other malignant disease (excluding basal and squamous skin cell carcinoma) within the last five years prior to entering the trial
    11.Allergy to aspirin or salicylate derivatives
    12.History of known hypersensitivity to the excipients used in the investigational medicinal products (IMPs)
    13.Chronic, dominant arthralgia or Rheumatoid arthritis
    14.Palpable abdominal mass
    15.Participation in another clinical trial within the last 3 months prior to enrolment
    16.Previous randomisation in the present trial
    17.Biologics (e.g. anti-TNF-α) must not be used during the trial or 6 months before Visit 1
    18.Continuous usage of systemic steroids (excluding budesonide) for 3 months or more within the past year
    19.Oral, rectal or i.v glucocorticosteroids must not be used during the trial or 2 weeks before Visit 1 (local treatments such as nasal sprays, inhalers and ointments are allowed at any time)
    20.Immunomodulating/suppressing drugs (e.g. azathioprine, 6-mercaptopurine, cyclosporine, tacrolimus and methotrexate): must not be used during the trial or 3 months before Visit 1
    21.Mesalazine, sulfasalazine and olsalazine compounds must not be used during the trial or 3 days before Visit 1
    22.Continuous usage of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) including salicylates must not be used (PRN/as needed use of NSAIDs, and treatment with low dose aspirin for prevention of cardiovascular diseases are allowed) during the trial or 2 weeks before Visit 1
    23.Antibiotics: must not be used during the trial or 1 week before Visit 1
    24.Intake of any kind of experimental treatment (e.g. cytokines, helminthics and probiotics) must not be used during the trial. Helminthics and cytokines must not be used 3 months before Visit 1
    25.Patients must not have donated blood for 12 weeks prior to Visit 1

    At Visit 2 (randomisation visit)
    26.Stool culture showing unwanted pathogens such as: Salmonella, Shigella, Campylobacter and/or Clostridium difficile toxins
    27.Patients who are unable to comply with the requirements of the protocol (e.g. alcohol or drug abuse, planned hospitalisation or any other condition associated with poor compliance)
    28.Positive pregnancy test.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of responders at Week 10. A responder is defined as a patient who achieved a reduction in the CDAI score to <150 or a decrease in CDAI score of at least 70
    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) 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    LPLV
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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) 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 No
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 510
    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 Decision2008-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-11-18
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