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    Summary
    EudraCT Number:2012-004214-34
    Sponsor's Protocol Code Number:HLS02/2012
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-11-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-004214-34
    A.3Full title of the trial
    Comparison of efficacy and acceptability of bisacodil and PEG-CS 2 L and PEG 4 L in patients with chronic inflammatory bowel disease: single center, randomized, single blind, parallel groups study
    Efficacia ed accettabilita' della associazione bisacodile e PEG-CS 2 litri in pazienti con malattia infiammatoria cronica intestinale: studio monocentrico, randomizzato, a singolo cieco, a gruppi paralleli, di confronto con PEG 4 litri
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of 2 low-volume products for the colonoscopy preparation in patients with IBD.
    Confronto di 2 prodotti a basso volume nella preparazione alla colonscopia in pazienti con malattia cronica intestinale.
    A.4.1Sponsor's protocol code numberHLS02/2012
    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 SponsorAZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
    B.1.3.4CountryItaly
    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 supportPromefarm
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera "Luigi Sacco"
    B.5.2Functional name of contact pointU. O. Gastroenterologia
    B.5.3 Address:
    B.5.3.1Street Addressvia G.B. Grassi, 74
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20157
    B.5.3.4CountryItaly
    B.5.4Telephone number02-39042207
    B.5.5Fax number02-39042337
    B.5.6E-mailmanes.gianpiero@hsacco.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 Yes
    D.2.1.1.1Trade name LOVOLDYL*30CPR RIV 5MG
    D.2.1.1.2Name of the Marketing Authorisation holderPROMEFARM Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Coated 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.3.9.3Other descriptive namebisacodyl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Yes
    D.3.11.13.1Other medicinal product typel'IMP verrà somministrato insieme a LOVOL-ESSE (dispositivo medico: macrogol, citrato, simeticone).
    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 Yes
    D.2.1.1.1Trade name SELG*OS POLV 4BUST 70G 1LT
    D.2.1.1.2Name of the Marketing Authorisation holderPROMEFARM Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Oral powder
    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.3.9.3Other descriptive namemacrogol
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    IBD patients undergoing a colonoscopy.
    pazienti con malattia infiammatoria cronica intestinale che si sottopongono a colonscopia.
    E.1.1.1Medical condition in easily understood language
    IBD patients.
    pazienti con malattia infiammatoria cronica intestinale.
    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 15.0
    E.1.2Level LLT
    E.1.2Classification code 10045282
    E.1.2Term UC
    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
    Comparison of 2 preparations for colon cleansing in patients with IBD undergoing a colonoscopy.
    Paragonare la efficacia di due preparazioni intestinali, bisacodile in combinazione con PEG-CS 2 litri e PEG 4 litri, per la pulizia intestinale prima della colonscopia nei pazienti affetti da IBD.
    E.2.2Secondary objectives of the trial
    Evaluation of safety and tolerability of 2 products.
    Valutare la visibilità mucosa, sicurezza, tollerabilità, gradimento e compliance da parte del paziente dei due prodotti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult outpatients (> 18 < 85 yrs), suffering from chronic inflammatory bowel disease, ulcerative colitis and Crohn’s disease, undergoing colonoscopy with different indications.
    Pazienti ambulatoriali di età &gt; 18 anni e &lt; 85, affetti da colite ulcerosa o malattia di Crohn, che devono sottoporsi a colonscopia per varie motivazioni, nel periodo di tempo compreso tra maggio e dicembre 2012.
    E.4Principal exclusion criteria
    Ileus, intestinal obstruction, toxic megacolon, colon perforation. Severe heart failure (New York Heart Association [NYHA] Class III or IV), acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure >100 mmHg), severe liver failure or ascites, end-stage renal failure, known or suspected intolerance or allergy to the study products. Women will be excluded from the study if pregnant or breastfeeding.
    Pazienti sottoposti a colonscopia in urgenza, che presentino un quadro di occlusione o sub-occlusione intestinale o di sospetta/accertata perforazione intestinale. Scompenso cardiaco congestizio classe III-IV secondo NYHA, malattie cardiovascolari acute, ipertensione arteriosa incontrollata (sistolica &gt;170 mmHg, diastolica &gt;100mmHg, cirrosi epatica con ascite, insufficienza renale grave. Donne in gravidanza o in allattamento. Intolleranza o allergia a uno dei componenti dei prodotti in preparazione.
    E.5 End points
    E.5.1Primary end point(s)
    Degree of colon cleansig will be assessed by the endoscopist, blind for the cleansing product, using the validated Ottawa scale.
    Valutare il grado di pulizia del colon.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 24 hours from the drug administration.
    Entro 24 ore dalla somministrazione del farmaco.
    E.5.2Secondary end point(s)
    Mucosal visibility according to the presence of bubbles assessed according the Milano scale.
    Safety: occurrence of clinically significant adverse events
    Tolerability: Occurrence and severity of specific symptoms, related to the product intake, ranked on a scale. They were also asked to rank the severity of specific symptoms, such as bloating, belching, nausea, abdominal pain, vomiting, dizziness, hunger, thirst, anal irritation or headache during the preparation period, as follows: 0 = absent, 1 = mild, 2 = moderate, 3 = severe.
    Acceptance of prepration: Patient acceptance of the preparation was evaluated by a predetermined questionnaire assessing interference with daily activity and sleeping, easiness in taking the product and the adjunctive clear fluid and performing the diet. Willingness to repeat the same preparation in the future (Yes/No) was also recorded.
    Patient compliance with the study treatment: It was assessed by a nurse who asked the patient whether s/he had completed the dosing regimen as prescribed; compliance was predefined as poor for patients who consumed less than 75% of cleansing solution
    Rate of complete colonoscopy and time to reach the coecum.
    Valutare la visibilità mucosa, sicurezza, tollerabilità, gradimento e compliance da parte del paziente dei due prodotti.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within 24 hours from the drug administration.
    Entro 24 ore dalla somministrazione del farmaco.
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    LVLS
    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 months40
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 214
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state264
    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)
    followed by the clinical center according to the GCP.
    presa in carico dal centro secondo il miglior standard clinico.
    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 Decision2012-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-31
    P. End of Trial
    P.End of Trial StatusOngoing
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