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    The EU Clinical Trials Register currently displays   44261   clinical trials with a EudraCT protocol, of which   7346   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).

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    Summary
    EudraCT Number:2011-004765-32
    Sponsor's Protocol Code Number:ST261-DM-11-005
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-25
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-004765-32
    A.3Full title of the trial
    Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST 261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates
    A.3.2Name or abbreviated title of the trial where available
    Propionyl-L-carnitine in Ulcerative Colitis
    A.4.1Sponsor's protocol code numberST261-DM-11-005
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSigma-Tau Industrie Farmaceutiche Riunite S.p.A.
    B.1.3.4CountryItaly
    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 supportSigma-Tau Industrie Farmaceutiche Riunite S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSigma-Tau Industrie Farmaceutiche Riunite S.p.A.
    B.5.2Functional name of contact pointCarla Cucco
    B.5.3 Address:
    B.5.3.1Street AddressViale Shakespeare, 47
    B.5.3.2Town/ cityRome
    B.5.3.3Post code00144
    B.5.3.4CountryItaly
    B.5.4Telephone number+39-06-91394322
    B.5.5Fax number+39-06-91166976
    B.5.6E-mailcarla.cucco@sigma-tau.it
    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 namePROPIONYL L-CARNITINE HYDROCHLORIDE
    D.3.2Product code ST 261
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNLevocarnitine propyl hydrochloride
    D.3.9.1CAS number 119793-66-7
    D.3.9.2Current sponsor code(ST261) Propionyl-L-carnitine
    D.3.9.3Other descriptive name(R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    mild non-infectious inflammation of the large bowel
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the two treatment groups (ST 261 modified release
    tablets 1g/die vs. placebo) with respect to the proportion of patients with disease remission at the end of the 8 weeks of treatment
    Evaluation of safety and tolerability of ST 261
    E.2.2Secondary objectives of the trial
    Maintenance of remission after four weeks of treatment interruption, the histological changes, the disease symptoms (sub-scores) improvement and the overall quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have read the Information for the Patient and signed the Informed Consent Form.
    2. Age comprised between 18 and 75 included.
    3. Diagnosis of active ulcerative colitis as confirmed endoscopically
    (pancolonoscopy) and histologically. A new pancolonoscopy is required if documented evidence of having performed it within the previous 12 months is not available. If available, only a new partial colonoscopy for the visualization of the affected part of the colon is required for the evaluation of the baseline DAI score.
    4. Rectal bleeding and stool frequency sub-scores have to be evaluated
    in occasion of the first patient's screening study visit (on the basis of the
    patient's memory of the episodes occurred during the previous two
    weeks, and considering the worst condition). At this time the rectal
    bleeding score must be at least 1.
    These two sub-scores will be re-evaluated (according to a paper diary
    recording) during the three days preceding the preparation for the baseline (pre-treatment) partial colonoscopy, to be performed as closest
    as possible to the conclusion of the screening period.
    Sub-scores recorded in occasion of the baseline (pre-treatment) partial
    colonoscopy will be utilised for the calculation of the baseline Disease
    Activity Index (DAI) score. At this time, patients are considered suitable for randomization if they have a Disease Activity index comprised between 3 and 6 inclusive (mild ulcerative colitis), with a rectal bleeding sub-score of at least 1.
    5. Stable background oral aminosalycilates (mesalazine, balsalazide, olsalazine) or sulfasalazine standard therapy for greater than or equal to 4 weeks prior to screening assessments.
    6. If female, not pregnant or nursing.
    7. For women of childbearing potential (WOCBP), willingness to avoid a pregnancy during the treatment period and for at least 4 weeks from the last dose of drug. A WOCBP is defined as any female who has experienced menarche and who has not ndergone
    successful surgical sterilisation (hysterectomy, bilateral tubal ligation or bilateral ovariectomy) or is not postmenopausal (defined as amenorrhoea >12 consecutive months). WOCBP should use an efficient method of birth control for the entire duration of the trial and until the first menses after a 30-day period after the last dose of trial medication. They must be on a stable regimen, for at least 1 month, of oral contraceptives, contraceptive implant or depot injection, contraceptive patch, intrauterine device (IUD), or condom and spermicidal agent. The patient will be informed about the results of the
    pregnancy test and of the allowed method of contraception and its
    duration.
    E.4Principal exclusion criteria
    1. Crohn’s disease and indeterminate colitis.
    2. Current or previous (in the last 10 days preceding the screening) use of systemic corticosteroids.
    3. Use of systemic antibiotics in the last 10 days preceding the screening.
    4. Use of systemic NSAIDs on a repeat basis in the last 10 days preceding the screening.
    5. Use of probiotics started within 10 days preceding the screening. A stable regimen from at least 10 days prior to screening is allowed but the patient must be willing to continue up to the end of the study.
    6. Patients previously treated with biological agents have to be
    excluded, as well as patients treated with immunosuppressants within
    the last 6 weeks preceding the screening.
    7. Stool culture positive for enteric pathogens (eg, Shigella, Salmonella, Yersinia, Campylobacter) or toxins (C.difficile), Parasites (i.e. Amoebae,
    Coccidia, Giardia, Helminths).
    8. Significantly impaired liver, renal, pulmonary or cardiovascular function as assessed by the investigator.
    9. History of colon resection.
    10. Diverticulitis, symptomatic diverticulosis.
    11. Active peptic ulcer disease.
    12. Proctitis (extent of inflammation <15 cm from the anus).
    13. Bleeding disorders (alterations of the coagulation factors or any
    concurrent other disease possibly causing digestive apparatus bleeding)
    14. Rectal therapy with any therapeutic enemas or suppositories with the exception of those required for endoscopy during the 10 days preceding the screening.
    15. Active or chronic infection(s) or malignancies.
    16. Known hypersensitivity to the active ingredient and excipients of the study drug.
    17. Simultaneous participation in another clinical trial, or participation in any clinical trial involving investigational drugs within 3 months from enrolment into the present study.
    18. Any physical or psychological condition in a patient that could let the investigator suspect his/her poor compliance.
    19. Patients treated with L-carnitine or its esters derivatives during the
    three months preceding the screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the clinical/endoscopic remission defined as a Disease Activity Index at the end of treatment ≤ 2 with rectal bleeding sub-score = 0 and no other individual sub-score >1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease Activity Index at the end of treatment ≤ 2 with rectal bleeding sub-score = 0 and no other individual sub-score > 1.
    E.5.2Secondary end point(s)
    Secondary endpoints will be:
    • Rectal bleeding evaluation by means of DAI sub-score (from 0 to 3).
    • Stool frequency evaluation by means of DAI sub-score (from 0 to 3).
    A clinical response for each of these parameters is defined as a sub-score improvement of at least 1 point over baseline.
    The histological response to the treatments, defined as an improvement of the Histological Index (HI – see Appendix III) of at least 1 point at the end of the study (a final HI score of ≤1 will be defined as a histological remission) will also be evaluated as additional exploratory end-point.
    The serum C-reactive protein and Fibrinogen will be monitored to investigate possible correlation between clinical/endoscopic outcome and serum level of these inflammatory markers.
    A validated specific questionnaire, the SIBDQ by McMaster University, will be administered to evaluate changes in patients’ Quality of Life.
    The safety and tolerability of the treatments will be investigated through AEs recording, vital signs, ECG and laboratory evaluation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    A clinical response for each of these parameters is defined as a sub-score improvement of at least 1 point over baseline.
    The histological response to the treatments, defined as an improvement of the Histological Index (HI – see Appendix III) of at least 1 point at the end of the study (a final HI score of ≤1 will be defined as a histological remission) will also be evaluated as additional exploratory end-point.
    The serum C-reactive protein and Fibrinogen will be monitored to investigate possible correlation between clinical/endoscopic outcome and serum level of these inflammatory markers.
    A validated specific questionnaire, the SIBDQ by McMaster University, will be administered to evaluate changes in patients’
    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 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.8.2.4Number of treatment arms in the trial2
    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 concerned3
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    Russian Federation
    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
    LVLS
    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 months1
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days9
    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.1.2.1Number of subjects for this age range: 444
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 444
    F.4.2.2In the whole clinical trial 444
    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)
    No
    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 Decision2012-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-13
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