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    Summary
    EudraCT Number:2006-001310-32
    Sponsor's Protocol Code Number:2006444
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-15
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2006-001310-32
    A.3Full title of the trial
    A double-blind, randomized, 6-week, parallel-group clinical
    trial to assess the safety and efficacy of Asacol 4.8 g/day
    (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg
    mesalamine tablet) for the treatment of moderately active
    ulcerative colitis (ASCEND III)
    A.3.2Name or abbreviated title of the trial where available
    ASCEND III
    A.4.1Sponsor's protocol code number2006444
    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 SponsorProcter & Gamble Technical Centres Limited
    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 nameAsacol 800 mg tablet
    D.3.4Pharmaceutical form Modified-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.3.9.2Current sponsor codemesalamine (USAN)
    D.3.9.3Other descriptive name5-aminosalicylic acid (5-ASA)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 nameAsacol 400 mg tablet
    D.3.4Pharmaceutical form Modified-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.3.9.2Current sponsor codemesalamine (USAN)
    D.3.9.3Other descriptive name5-aminosalicylic acid (5-ASA)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Ulcerative Colitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009900
    E.1.2Term Colitis ulcerative
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To confirm the clinical benefits of Asacol 4.8 g/day (800 mg tablet) compared to
    Asacol 2.4 g/day (400 mg tablet) in patients with moderately active ulcerative colitis
    using the Physician’s Global Assessment (PGA).
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) compared to
    Asacol 2.4 g/day (400 mg tablet) in male patients with moderately active UC;
    - To evaluate the change in each of the individual assessments and composite scores (PGA and modified Mayo Score) at Week 6;
    - To evaluate the change in the individual assessments of stool frequency, rectal bleeding, and PFA at Week 3;
    - To evaluate treatment success in patients with left-sided disease at Week 6.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients, who
    a) are willing and able to provide written informed consent;
    b) are male or female between 18 and 75 years of age, inclusive, at Screening;
    c) have a confirmed diagnosis of moderately active ulcerative colitis, extending proximally beyond 15 cm from the anal verge, as confirmed by flexible sigmoidoscopy or colonoscopy performed within 7 days prior to the Baseline Visit.
    d) have a confirmed diagnosis of moderately active disease (PGA = 2, see Appendix 7.7) at the Baseline Visit;
    e) have, at the Baseline Visit, a score of at least 1 in both the stool frequency and rectal bleeding clinical assessments and a score of at least 2 in the Sigmoidoscopy Assessment Score (Appendix 7.3);
    f) if female, must be (as documented by verbally offered medical history):
    • postmenopausal (at least 1 year without spontaneous menses), or
    • surgically sterile (tubal ligation or hysterectomy at least 6 months prior to
    enrollment), or
    • using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal
    contraception [at least 3 months prior to enrollment], sexual partner with nonreversed vasectomy [with azoospermia in 2 tests], 2 barrier methods [e.g., condom, diaphragm, or spermicide], or intra-uterine device). Women who are using
    contraception will be required to have a pregnancy test (urine or serum) at the
    Screening Visit and at the Week 6/Exit Visit.
    E.4Principal exclusion criteria
    Patients, who have/are
    a) received a dose of a product that contains or is metabolized to mesalamine by any route from which more than 1.6 g/day of mesalamine was available within 7 days before the Screening Visit;
    b) UC confined to rectum (isolated ulcerative proctitis);
    c) a history of allergy or hypersensitivity to salicylates, aminosalicylates, or any component of the Asacol tablet;
    d) a history or presence of any condition causing malabsorption or an effect on
    gastrointestinal motility or history of extensive small bowel resection (greater than one half the length of the small intestine) causing short bowel syndrome;
    e) a current abuser of drugs or alcohol;
    f) a history of HIV infection or AIDS;
    g) a significant co-existing illness or other condition(s) that, in the judgment of the
    Investigator, contraindicate(s) administration of the study drug and/or any study
    procedures;
    h) current renal disease (serum creatinine more than 1.5 times the upper limit of normal at Screening Visit) or documented history of hepatic disease (aspartate transaminase [AST] or alanine transaminase [ALT] more than 2 times the upper limit of normal);
    i) previously participated in this study;
    j) participated in any drug or device clinical study within 30 days before study entry;
    k) currently enrolled in any other clinical study;
    l) received any oral, intravenous, intramuscular, or rectally administered corticosteroids (including budesonide) within 30 days before the Screening Visit;
    m) received any other topical rectal therapy during the 7 days before the Screening Visit;
    n) received immunomodulatory therapy including, but not limited to, rosiglitazone,
    6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 90 days before the Screening Visit;
    o) received infliximab, certolizumab, or other biologic treatment of ulcerative colitis within 90 days before the Screening Visit;
    p) received antibiotics, other than topical antibiotics, within 7 days before the Screening Visit;
    q) used any product containing omega-3 (fish) oils within 7 days before the Screening Visit;
    r) received aspirin (except for cardioprotective reasons up to a maximum dose of
    325 mg/day) or other NSAIDs within 7 days before the Screening Visit;
    s) received any anti-diarrheals, and/or anti-spasmodics within 3 days before the Screening Visit;
    t) stool examination positive for Clostridium difficile, bacterial pathogens, or ova and
    parasites;
    u) if female, positive pregnancy test (serum or urine) or lactating
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the proportion of patients in each treatment group who achieve treatment success, defined as improvement from baseline at Week 6. Improvement is defined as either a complete response (remission) or a partial response (improvement) to treatment. A complete response is defined as a Physician’s Global Assessment (PGA) of zero (PGA = 0), i.e., complete resolution or normalization of all of the following: stool frequency, rectal bleeding, and Sigmoidoscopy Assessment Score. A partial response is defined as improvement from baseline in the PGA and no worsening in any of the 3 component endpoints.
    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 Yes
    E.6.4Safety Yes
    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 Yes
    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) Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    The study is considered terminated upon completion of all patient treatments and evaluations (all patients having completed the Week 6/Exit visit)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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 2006-05-15. 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 420
    F.4.2.2In the whole clinical trial 770
    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)
    Subsequent patient management will be as determined by the Investigator according to appropriate medical practice.
    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 Decision2006-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-06-25
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