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    Summary
    EudraCT Number:2004-000733-12
    Sponsor's Protocol Code Number:SPD476-301
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-07-01
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2004-000733-12
    A.3Full title of the trial
    A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.
    A.4.1Sponsor's protocol code numberSPD476-301
    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 Inc
    B.1.3.4CountryUnited States
    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 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.3.1Product nameMesalazine
    D.3.2Product code SPD476
    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 INNMesalazinum
    D.3.9.1CAS number 89-57-6
    D.3.9.2Current sponsor codeSPD476
    D.3.9.3Other descriptive name5-amino salicylic acid (5-ASA)
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboProlonged-release 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
    Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses<to baseline) mild to moderate ulcerative colitis (UC). The original diagnosis of UC (total score of 4-10 on the Ulcerative Colitis Disease Activity Index and with a sigmoidoscopy score of >1 and a Physician Global Assessment of <2). The original diagnosis of UC must be established by sigmoidoscopy, colonoscopy, or barium enema and have compatible histology.
    MedDRA Classification
    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 percentage of subjects in remission after 8 weeks of treatment for the three treatment groups SPD476 2.4 g/day given twice daily and 4.8 g/day given once daily and placebo. Remission is defined as an Ulcerative Colitis Disease Activity Index (UC-DAI) score <1, with score of zero for rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of 1 point or more from baseline.
    E.2.2Secondary objectives of the trial
    - To compare the percentage of subjects achieving clinical improvement at week 8 as defined by a drop of >3 points from baseline in the overall UC-DAI score for the three treatment groups.
    - To compare the percentage subjects in remission after 8 week of treatment between two doses of SPD476.
    - To compare the change in the UC-DAI score from baseline to 8 week of treatment between the three treatment groups.
    - To compare the change in symptoms (rectal bleeding and stool frequency) from baseline to 2,4 and 8 weeks of treatment between the three treatment groups.
    - To compare the time to withdrawal between the 3 treatment groups.
    To compare the change in sigmoidoscopic (mucosal)appearance from baseline to 8 weeks of treatment between the 3 treatment groups.
    - To assess the safety and tolerability of SPD476 administered as 2.4 g/day given BID and 4.8 g/day given OD as compared to placebo.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Adults aged 18 and over, male and female
    -Women of childbearing potential must use an effective contraceptive method while the subject is on the study treatment and must agree to not become pregnant during 30 days after the last dose of the study drug.
    - Subject who are newly diagnosed or have diagnosis of relapsing mild to moderate UC. Diagnosis of UC originally must be established by sigmoidoscopy, colonoscopy, or barium enema and have compatible histology.
    - Subjects who, in the investigator's opinion are not likely to respond to 5-ASA doses of 2.4 g/day should not be included.
    E.4Principal exclusion criteria
    -Severe UC according to the Physicians Global Asswssmant or subjects that have been in relapse for >6 weeks prior baselina.
    - Subjects who have relapsed on maintenance therapy with doses of 5-ASA>2g/day.
    If a subject had a recent 5-ASA dose reduction from >2g/day to <2g/day relapses within 2 weeks of thatv dose reduction, the subject will not be eligible .
    - Cron's Disease, proctitis, bleeding disorder, or active ulcer disease.
    -Subjects with Asthma if they are known to be 5-ASA sensitive.
    -Subjects who in the opinion of the investigator are at immediate or significant risk of toxic megacolon.¨
    -Previous colon surgary.
    - Subjects with moderate or severe renal impairment (defined as a creatinine level of >2 mg/dl) are contra-indicated for the treatment with 5-ASA compounds
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for this study is remission assessed by the UC-DAI score. It consists of 4 individual parameters (stool frequency, rectal bleeding, mucosal appearance and Physicians Global Assessment). All 4 parameters will be assessed individually on a scale from 0-3.
    Remission is defined as an UC-DAI score of <1, with score of zero for stool frequency and rectal bleeding and sigmoidoscopy score reduction of 1 point or more from baseline.
    Improvement of symptoms from baseline to 2,4, and 8 weeks will be assessed by using two individual parameters of the UC-DAI: stool frequency, rectal bleeding.
    Safety and tolerability will be assessed by adverse events, laboratory testing (hematology, biochemistry and urinalysis), physical examination and vital signs.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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.8.5The 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 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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 Information not present in EudraCT
    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 2004-07-01. 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 255
    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)
    Standard treatment, or if the patients qualify they can roll into the open label extension, the SPD476-303 study
    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 Decision2004-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-20
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