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    Summary
    EudraCT Number:2013-001259-11
    Sponsor's Protocol Code Number:80-83600-98-10006
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-12-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-001259-11
    A.3Full title of the trial
    Tacrolimus suppositories versus beclomethason suppositories for the treatment of proctitis refractory to local 5-ASA.
    De effecten van tacrolimus zetpillen vergeleken met beclomethason zetpillen bij patiënten met een proctitis ulcerosa niet reagerend op mesalazine zetpillen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    tacrolimus suppositories versus beclomethason suppostories for the treatment of proctitis refractory to local 5-ASA.
    De effecten van tacrolimus zetpillen vergeleken met beclomethason zetpillen bij patiënten met een proctitis ulcerosa niet reagerend op mesalazine zetpillen
    A.3.2Name or abbreviated title of the trial where available
    The TSP study
    A.4.1Sponsor's protocol code number80-83600-98-10006
    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 SponsorZon MW
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZon MW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointCJ van der Woude
    B.5.3 Address:
    B.5.3.1Street Addresss Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CE
    B.5.3.4CountryNetherlands
    B.5.6E-mailc.vanderwoude@erasmusmc.nl
    D. IMP Identification
    D.IMP: 1
    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 nametacrolimus
    D.3.4Pharmaceutical form Suppository
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.9.2Current sponsor codenone
    D.3.9.3Other descriptive namenone
    D.3.9.4EV Substance CodeSUB10797MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.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 namebeclomethason suppository
    D.3.4Pharmaceutical form Suppository
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBECLOMETASONE DIPROPIONATE
    D.3.9.1CAS number 5534-09-8
    D.3.9.2Current sponsor codenone
    D.3.9.3Other descriptive namenone
    D.3.9.4EV Substance CodeSUB00681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Refractory and/of recurrent ulcerative proctitis
    E.1.1.1Medical condition in easily understood language
    difficult to treat or not responding to treatment ulcerative proctitis
    Moeilijk behandelbare ontsteking van de endeldarm (proctitis ulcerosa)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    Primary outcome:
    Number of patients in remission responding to treatment with tacrolimus compared to beclomethason, using the validated Disease Activity Index (D.A.I) and an endoscopic score to compare the disease activity before and after treatment. The primary end point will be the proportion of patients in clinical and endoscopic remission (colitis disease activity index of < or =1 with rectal bleeding and stool frequency scores of 0, no mucosal friability, and a > or =1-point reduction in sigmoidoscopy score from baseline).
    E.2.2Secondary objectives of the trial
    Secondary outcomes:
    Proportion of patients responding (the proportion of patients achieving clinical improvement (defined as a decrease of ≥3 points from baseline in the total DAI score)); the changes in sigmoidoscopic mucosal appearance (baseline to week 4)
    Safety and tolerability of tacrolimus and beclomethason.
    Histopathology from biopsies taken before and after treatment (grading scale (0 _ structural changes only, 1_ chronic inflammation, 2 _ lamina propria neutrophils, 3_ neutrophils in epithelium, 4 _ crypt destruction, 5 _ erosions or ulcers).
    Quality of life.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Endoscopically or histologically proven ulcerative proctitis at least 3 months before randomization.
    Proctitis is defined as: disease activity to 20 cm beyond the anal verge.
    Refractory proctitis defined as a failure to at least the use of 5-asa suppositories of a maximum of 1 gram for at least 28 days and recurrent proctitis is defined as relapse within 3 months after stopping of local adequate 5-asa treatment.
    Endoscopy may have been performed up to 3 weeks before screening, if the endoscopy was well documented and biopsies were taken.
    Age: 18-70 years and written informed consent.
    Permitted concomitant therapy: oral aminosalicylates, azathioprine, 6-mercatopurine and methotrexate at stable dose for 12 weeks
    E.4Principal exclusion criteria
    Use of enemas: 5-asa or beclamethason
    Infliximab or other anti TNF treatment within 12 weeks prior to randomization
    Teatment with tacrolimus prior to randomization
    Treatment with any investigational drug within 12 weeks of randomization
    Abnormal renal function
    Pre-existent leucopenia or thrombopenia
    - Neutrophil count 1,800/mm3
    - Platelets 90,000/mm3
    Liverfunction tests abnormalities (>2 ULN).
    Other significant medical illness that might interfere with this study: current malignancy
    Immunodeficiency syndromes.
    Any known pre-existing medical condition that could interfere with the patient's
    participation in and completion of the study such as: - Preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded. Severe depression would include the
    following: (a) subjects who have been hospitalized for depression, (b) subjects who have received electroconvulsive therapy for depression, or (c) subjects whose depression has resulted in a prolonged absence of work and/or significant disruption of daily functions. Subjects with a history of mild depression may be considered for entry into the protocol provided that a pretreatment assessment of the subject’s mental status supports that the
    subject is clinically stable and that there is ongoing evaluation of the patient’s mental status during the study
    - CNS trauma or active seizure disorders requiring medication
    - Significant cardiovascular dysfunction within the past 6 months (e.g.,angina, congestive heart failure, recent myocardial infarction, severehypertension or significant arrhythmia).
    - Poorly controlled diabetes mellitus
    - Significant pulmonary dysfunction/ chronic disease (e.g., chronic obstructive pulmonary disease)
    - Renal insufficiency (elevated serum creatinin)
    Pregnancy, Lactation
    Substance abuse, such as alcohol (80 gm/day), I.V. drugs and inhaled drugs. If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 years. Subjects receiving methadone within the past 2 years are also excluded Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the study.
    Positive stool culture for enteric pathogens
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients in remission responding to treatment with tacrolimus compared to beclomethason, using the validated Disease Activity Index (D.A.I) and an endoscopic score to compare the disease activity before and after treatment. The primary end point will be the proportion of patients in clinical and endoscopic remission (colitis disease activity index of < or =4 with rectal bleeding and stool frequency scores of 0, no mucosal friability, and a > or =1-point reduction in sigmoidoscopy score from baseline).

    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 2, 4 and 12: clinical response (DAI)
    Week 4 endoscopic remission
    E.5.2Secondary end point(s)
    Proportion of patients responding (the proportion of patients achieving clinical improvement (defined as a decrease of ≥3 points from baseline in the total DAI score)); the changes in sigmoidoscopic mucosal appearance (baseline to week 4)
    Safety and tolerability of tacrolimus and beclomethason.
    Histopathology from biopsies taken before and after treatment (grading scale (0 _ structural changes only, 1_ chronic inflammation, 2 _ lamina propria neutrophils, 3_ neutrophils in epithelium, 4 _ crypt destruction, 5 _ erosions or ulcers).
    Quality of life.

    E.5.2.1Timepoint(s) of evaluation of this end point
    week 2, 4 and 12: safety, clinical response
    week 4 endoscopic response and histological response
    week 2,4 and 12:quality of life
    week 2,4 and 12: safety and tolerability of tacrolimus and beclomethason
    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 No
    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 No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state88
    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)
    none
    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 Decision2013-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-19
    P. End of Trial
    P.End of Trial StatusOngoing
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