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    The EU Clinical Trials Register currently displays   42336   clinical trials with a EudraCT protocol, of which   6971   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-004384-75
    Sponsor's Protocol Code Number:37970
    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:2012-09-10
    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 number2011-004384-75
    A.3Full title of the trial
    Randomized controlled trial: Picoprep versus Moviprep for efficacy, safety and patient tolerability in colonoscopy bowel preparation.
    Gerandomiseerd onderzoek naar de werkzaamheid, veiligheid en patienten acceptatie van Picoprep versus Movioprep bij de voorbereiding voor een coloscopie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is Picoprep and Moviprep equally adequate, safe and tolerable in the adequate bowel cleansing for colonosocpy?
    Is Picoprep en Moviprep even effectief, veilig en acceptabel bij de voorbereiding voor een coloscopie?
    A.3.2Name or abbreviated title of the trial where available
    PicoMovi
    A.4.1Sponsor's protocol code number37970
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 picoprep
    D.2.1.1.2Name of the Marketing Authorisation holderFerring BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namepicoprep
    D.3.2Product code RGV 106616
    D.3.4Pharmaceutical form Powder for oral solution
    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 INNSODIUM PICOSULFATE
    D.3.9.1CAS number 10040-45-6
    D.3.9.4EV Substance CodeSUB10569MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmagnesium oxide
    D.3.9.1CAS number 3344-18-1
    D.3.9.3Other descriptive nameMAGNESIUM CITRATE
    D.3.9.4EV Substance CodeSUB14422MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNanhydrous citric acid
    D.3.9.1CAS number 77-92-9
    D.3.9.3Other descriptive nameANHYDROUS CITRIC ACID
    D.3.9.4EV Substance CodeSUB16203MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 Yes
    D.2.1.1.1Trade name moviprep
    D.2.1.1.2Name of the Marketing Authorisation holderNorgine
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namemoviprep
    D.3.2Product code RVG 34072
    D.3.4Pharmaceutical form Powder for oral solution
    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.3.9.1CAS number 8000014-43-9
    D.3.9.3Other descriptive nameMACROGOL 4000
    D.3.9.4EV Substance CodeSUB14400MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 7757-82-6
    D.3.9.3Other descriptive nameSODIUM SULPHATE, ANHYDROUS
    D.3.9.4EV Substance CodeSUB12308MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNASCORBIC ACID
    D.3.9.1CAS number 50-81-7
    D.3.9.4EV Substance CodeSUB05579MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10,6
    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
    Patients who need a colonoscopy for screening, surveillance or diagnosis of a disease have to be prepared by bowel cleansing
    Patienten die een coloscopie moeten ondergaan vanwege screening, opvolging of diagnose van een ziekte moeten darmvoorbereiding krijgen
    E.1.1.1Medical condition in easily understood language
    Polyp detection and removal, detection of large bowel cancer and diagnosis of defecation problems by colonoscopy after adequate bowel cleansing
    Ontdekken en verwijderen van poliepen, opsporen van darmkanker en diagnose van defecatie klachten via colonoscopy na adequate darmvoorbereiding
    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 10010009
    E.1.2Term Colonoscopy and sigmoidoscopy abnormal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10010010
    E.1.2Term Colonoscopy and sigmoidoscopy normal
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Colonoscopy is considered the reference standard for detection of colonic neoplasia. Polyp detection is dependent on quality standards including colonoscopist and patient related factors. Optimal bowel preparation is associated with lower polyp miss rates. Improving tolerability of bowel cleansing may encourage patient compliance. Lowering the intake of bowel preparation would increase patient tolerability. We hypothesize that the small dose Picoprep is as efficacious for bowel cleansing as small dose Moviprep (PEG) and that Picoprep is as safe as Moviprep and may be more tolerable for patients.
    Coloscopie is de standaard voor de detectie van darmkanker en darmpoliepen. Het ontdekken van poliepen is afhankelijk van de ervaring van de endoscopist en de voorbereiding van de patient. Optimale darmvoorbereiding is geassocieerd met het minder missen van poliepen maar wel een belasting voor de patient. Vermindering van het in te nemen volume zal de patiententrouw doen toenemen.We veronderstellen dat een de verminderde dosering bij het gebruik van picoprep en moviprep dezelfde goede voorbereiding zal geven en dezlefde veiligheid, maar dat de kleinere dosis van picoprep de acceptatie van de patient zal vergroten.
    E.2.2Secondary objectives of the trial
    Patient safety by blood sampling and telephone contact
    Veiligheid voor de patient door afname van bloed en nabellen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient 18 years and older, who have to uindergo a colonoscopy and who are able to give their informed consent and are eligible to undergo bowel-cleansing
    Patienten ouder dan 18 jaar bij wie een indicatie bestaat voor coloscopie en die in staat zijn hun informed consent te geven en die de darmvoorbereiding kunnen ondergaan
    E.4Principal exclusion criteria
    Patients with significant gastroparesis or gastric outlet obstruction; ileus; known or suspected bowel obstruction or perforation; severe chronic renal failure (creatinine clearance < 30mL/minute); severe congestive heart failure (AHA class III or IV); toxic colitis or megacolon. Also, patients with a subtotal colectomy or a colostomy will be excluded because of insufficient remaining colonic surface to evaluate the effects of bowel cleansing.
    Patienten met significant gastroparese of maaguitgangsstenose; ileus; bekende of vermoede darm obestructie of perforatie; ernstig nierlijden (kreatinine klaring < 30mL/minute); ernstig hartfalen (AHA classe III or IV); toxische colitis of megacolon. Patienten met een subtotale colectomie of een colostoma worden uitgesloten omdat er te weinig overblijvend darmoppervlakte is voor een effectieve beoordeling.
    E.5 End points
    E.5.1Primary end point(s)
    Preparation efficacy is evaluated by the blinded colonoscopist. Bowel preparation is assessed by the validated Ottawa Bowel Preparation Scale and the Boston Bowel Preparation Scale based on the preparation scores from three segments of the colon (right colon, transverse colon and left colon), as well as a score for overall colonic fluid. A questionnaire is used to assess tolerance of the bowel preparation. This questionnaire is will assess items as bloating, cramping, nausea and overall burden. All items are scored on a 5-point Likert scale.
    De darmvoorberiding wordt blind door de endoscopist beoordeeld aan de hand van 2 gevalideerde vragenlijsten (Ottawa Bowel Preparation Scale and the Boston Bowel Preparation Scale) die de 3 segmenten van het colon (rechter, transversum en linker) colon scoren en een score geven voor de hoeveelheid vocht. tevens wordt met een vragenlijst de tolerantie van de darmvoorbereiding zoals opgeblazen gevoel, misselijkheid, braken, belasting inschatten op een 5-punts Likert schaal.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endoscopist once after the colonoscopy, patient once after taking the preparation.
    De endoscopist direct na de coloscopy, de patient na inname van de darmvoorbereiding
    E.5.2Secondary end point(s)
    Adverse events will be recorded for 30 days after colonoscopy. Blood will be collected after the prep and right before the procedure to assess electrolyte shifts and tested for bicarbonate, blood urea nitrogen, calcium, chloride, creatinine, magnesium, phosphate, potassium, sodium, haemoglobin and hematocrite.
    Compliacties worden gedurende 30 dagen na de coloscopie opgevolgd. Bloed wordt afgenomen voor de start en na het voltooien van de voorbereiding en onderzocht op bicarbonaat, ureum, calcium, chloor, kreatinine, magnesium, fosfaat, kalium, natrium, haemoglobine and hematocriet.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood sampling twice and a telephone call after 30 days
    Tweemaal bloedafname en een telefonische afspraak na 30 dagen.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    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 No
    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.8.5The 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
    End of study by LVLS
    Einde studie bij de laatste visite van laatste patient
    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 months6
    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.1.1.1In 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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state340
    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)
    Care for patients after the trial should be needed when an adverse event occurs. Electrolyte disturbances may tbe present in the worst case and will be coreected by intravenous fluids
    Patienten die door de voorbereiding een stoornis in de electroliten krijgen zullen worden opgenomen om dit met een infuus te correigeren
    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 Decision2012-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-17
    P. End of Trial
    P.End of Trial StatusOngoing
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