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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41231   clinical trials with a EudraCT protocol, of which   6758   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) .
     
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    Summary
    EudraCT Number:2004-004077-29
    Sponsor's Protocol Code Number:2004112
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-23
    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 number2004-004077-29
    A.3Full title of the trial
    A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis
    A.4.1Sponsor's protocol code number2004112
    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 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.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 Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRDP58
    D.3.2Product code RDP58
    D.3.4Pharmaceutical form Capsule, soft
    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 INNDelmitide acetate
    D.3.9.1CAS number 501019-16-5
    D.3.9.2Current sponsor codeRDP58
    D.3.9.3Other descriptive nameSF257 C59
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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 Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namemesalazine
    D.3.4Pharmaceutical form 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 89-57-6
    D.3.9.3Other descriptive name5-Aminosalicylic Acid
    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 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 placeboCapsule, soft
    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 is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain.
    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
    The primary objective of this study is to assess the efficacy and safety of adding 200 mg or 600 mg daily oral RDP58 to 2.4 g/day of oral mesalazine background therapy vs. 4.8 g/day oral mesalazine for induction of complete remission of moderately active ulcerative colitis (UC) at Day 56.

    Moderately active UC is defined as a Mayo Score of 7-11 plus a Modified Baron’s Sigmoidoscopy Score ≥ 2 (based on the Investigator’s assessment). Complete remission is defined as:
    • A Modified Baron’s Sigmoidoscopy Score of 0 or 1, based on the investigator’s assessment, and
    • Complete resolution of rectal bleeding (RB = 0), and
    • Complete resolution of stool frequency (SF = 0).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess the impact of adding 200 mg or 600 mg daily oral RDP58 to 2.4 g/day of oral mesalazine background therapy vs. 4.8 g/day oral mesalazine in patients with moderately active UC for achieving the following at Day 56:
    • Complete remission (as defined above) in patients who entered the study with rectal bleeding and increased stool frequency.
    • Complete remission or partial response in those patients who entered the study with rectal bleeding and increased stool frequency. Partial response is defined as improvement from Baseline in the PGA, accompanied by improvement in at least 1 other category of symptoms or findings (stool frequency, rectal bleeding, or Modified Baron’s Sigmoidoscopy Score) and no worsening in any of the remaining categories.
    • Improvement in histology from rectal biopsy at Day 56.
    • Complete remission (as defined above) based on the central facility assessment of the sigmoidoscopy at Baseline and Day 56.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients meeting all of the following criteria will be considered for admission to the study:
    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) If female, must be (as documented in patient notes):
    • 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, or
    • have a sexual partner with non-reversed vasectomy (with confirmed azoospermia), or
    • be using 2 barrier methods (e.g., condom, diaphragm, spermicide, or intra-uterine device).
    Women who are using contraception will be required to undergo pregnancy testing at Screening, Baseline, Day 28, Day 56, and Day 84.
    d) Have a confirmed diagnosis of moderately active ulcerative colitis, extending proximally beyond 15 cm from the anal verge, as confirmed by flexible sigmoidoscopy performed within 7 days prior to Baseline (Day 1). Moderately active disease is defined as a Mayo Score of 7-11 (see Appendix 1) and a Modified Baron's Sigmoidoscopy Score of 2 or 3 on the flexible sigmoidoscopy (see Appendix 1). The sigmoidoscopy score will be supported by photograph (video is preferred, but still photographs are also acceptable).
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    a) Isolated proctitis;
    b) A history or presence of any condition causing malabsorption or an effect on gastrointestinal motility or history of extensive small bowel resection (> ½ the length of the small intestine);
    c) Documented diagnosis of a current renal or hepatic disease;
    d) History of a positive test for HIV;
    e) Current abuse of alcohol or use of illicit drugs;
    f) Change in use of nicotine products within 7 days prior to Screening;
    g) Use of anti-spasmodic or anti-diarrheal agents within 7 days prior to Baseline;
    h) Multiple food/drug allergies, or a known hypersensitivity to 5-ASA or salicylates;
    i) Laboratory values outside the local laboratory reference range as follows:
    • blood urea nitrogen (BUN) or serum creatinine level > 1.5 times the upper limit of normal,
    • liver enzyme test (alkaline phosphatase, aspartate transaminase [AST/SGOT], alanine transaminase [ALT/SGPT], total bilirubin, or gamma glutamyl transferase [GGT] level > 2 times the upper limit of normal,
    • positive stool examination for ova and parasites, positive culture for bacterial pathogens, or presence of Clostridium difficile toxin;
    • any other laboratory abnormality that the Investigator considers clinically significant to the patient’s participation in the trial;
    j) If female, a positive pregnancy test, or actively breast-feeding;
    k) Participation in a previous study of RDP58;
    l) A significant co-existing illness or other medical or psychological condition that, in the judgment of the Investigator, contraindicate(s) administration of the study drug and/or any study procedure(s);
    m) Dependence on steroids (delivered by any route);
    n) Patients who have received the following will be excluded from study entry:
    • Intravenous or intramuscularly administered corticosteroids within 1 month prior to the Baseline visit (including Budesonide);
    • Oral steroids in excess of prednisone 15 mg/day or its equivalent (in patients not considered to be steroid-dependent). Patients entering the study on an oral steroid at a dose of ≤ 15 mg/day oral prednisone or its equivalent must have been maintained on their current dose for at least 14 days. At the investigator’s discretion, corticosteroids can be decreased if the subject has achieved a complete remission. In this instance, flexible sigmoidoscopy, without rectal biopsy, must be performed to define the patient’s Modified Baron’s Sigmoidoscopy Score prior to a planned decrease in the dose of the oral steroid.
    • Any other topical rectal therapy during the 7 days prior to the Screening visit;
    • Received immunomodulator therapy including, but not limited to, 6-mercaptopurine, azathioprine or methotrexate within 3 months prior to the Baseline visit;
    • Exposure to cyclosporine at any time;
    • Drugs that possibly affect expression of tumor necrosis factor (e.g., pentoxifyline and infliximab);
    • Any mesalazine-containing compound by any route from which more than 2.4 g/day of mesalazine was available within 7 days prior to the Screening visit (NOTE: 6 g/day of sulfasalazine and 6.75 g/day of balsalazide are equivalent to 2.4 g/day of mesalazine);
    • Antibiotics (other than topical antibiotics) and metronidazole, within 7 days prior to the Screening visit.
    • Any experimental or investigational drug, device or procedure during the 1-month period prior to the Baseline visit;
    o) Any of the following coexisting conditions:
    • A history of malignancy other than non-melanoma skin cancer or cervical intra-epithelial neoplasia;
    • Toxic megacolon;
    • Physical or radiologic evidence of an abdominal abscess;
    • Conditions requiring imminent surgical intervention;
    • Dependence on total parenteral nutrition;
    • Inability to tolerate fluids by mouth;
    • Presence of colostomy or ileostomy or a history of colectomy.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint to be measured is the proportion of patients in each treatment group who achieve complete remission of moderately active UC at Day 56. Moderately active UC is defined as a Mayo score of 7-11 and a Modified Baron’s Sigmoidoscopy Score ≥ 2. Complete remission is defined as follows:
    • Modified Baron’s Sigmoidoscopy Score of 0 or 1, and
    • Complete resolution of rectal bleeding (RB = 0), and
    • Complete resolution of stool frequency (SF = 0).
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 2005-02-23. 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.3.3.6.1Details of subjects incapable of giving consent
    Women of childbearing potential must be

    •using acceptable contraception at least 3 months prior to enrollment, or

    •have a sexual partner with non-reversed vasectomy, or

    •be using 2 barrier methods
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 250
    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 Decision2005-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-02-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-11-18
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