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    Summary
    EudraCT Number:2012-002495-13
    Sponsor's Protocol Code Number:SPD555-403
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-04
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-002495-13
    A.3Full title of the trial
    An Open-label, Randomized, Crossover, Reader-blinded Study
    To Investigate the Effect of Prucalopride and Polyethylene Glycol
    3350 on Colon Motility with Intraluminal Manometry in Subjects
    with Chronic Constipation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study To Investigate Prucalopride vs. Polyethylene Glycol 3350 on Colon Activity
    A.4.1Sponsor's protocol code numberSPD555-403
    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 SponsorShire-Movetis NV
    B.1.3.4CountryBelgium
    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 supportShire-Movetis NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire-Movetis
    B.5.2Functional name of contact pointMedical Communications
    B.5.3 Address:
    B.5.3.1Street AddressVeedijk 58 (1004)
    B.5.3.2Town/ cityTurnhout
    B.5.3.3Post codeB-2300
    B.5.3.4CountryBelgium
    B.5.4Telephone number003214404390
    B.5.5Fax number00321440391
    B.5.6E-mailshire-movetis.clinicaltrials@shire.com
    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 Resolor 2 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderShire-Movetis
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-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.3.8INN - Proposed INNResolor
    D.3.9.2Current sponsor codeSPD555
    D.3.9.3Other descriptive namePRUCALOPRIDE SUCCINATE
    D.3.9.4EV Substance CodeSUB28850
    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 Yes
    D.2.1.1.1Trade name Movicol
    D.2.1.1.2Name of the Marketing Authorisation holderNorgine Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameMovicol 13.8g sachet, powder for oral solution
    D.3.4Pharmaceutical form Powder and solvent 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 INNMovicol
    D.3.9.3Other descriptive nameMACROGOL 3350
    D.3.9.4EV Substance CodeSUB20628
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number104.8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMovicol
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.806
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMovicol
    D.3.9.3Other descriptive nameSODIUM BICARBONATE
    D.3.9.4EV Substance CodeSUB12643MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.428
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMovicol
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number372.8
    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
    Chronic Constipation
    E.1.1.1Medical condition in easily understood language
    constipation
    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
    To evaluate differences in pharmacodynamic effects of prucalopride and PEG 3350 + electrolytes on the number of colonic HAPC during a 12-hour intraluminal manometry in chronically constipated subjects.
    E.2.2Secondary objectives of the trial
    • To evaluate the association between motility parameters and number and consistency of bowel movements in chronically constipated subjects receiving a single dose of prucalopride and 2 doses of PEG 3350 + electrolytes
    • To explore the relationship between plasma concentrations and pharmacodynamic endpoints in chronically constipated subjects.
    • To collect pharmacogenomic data in chronically constipated subjects for exploratory purposes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting all of the criteria listed below will be included in the study:
    1. Male or female age 18-75 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of screening. This inclusion criterion will only be assessed at the first Screening Visit.
    2. Willingness to comply with any applicable contraceptive requirements of the protocol and is:
    – Non-pregnant, non-lactating female
    – Females must be at least 90 days postpartum or nulliparous.
    – Females of childbearing potential should have a negative serum pregnancy test at the Screening Visit and should use a medically-acceptable method of birth control for the entire duration of the study and until the first menses after a 30-day period after the last dose of investigational product. 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), condom and spermicidal agent, or diaphragm and spermicidal agent, or agree upon continuous abstinence from heterosexual sexual contact and be willing to continue this contraception.
    3. Subject has a history of chronic constipation for at least 6 months before the Screening Visit and reports an average of <3 SCBMs per week and 1 or more of the following:
    • Very hard (little balls) and/or hard stools at least a quarter of the stools
    • Sensation of incomplete evacuation following at least a quarter of the stools
    • Straining at defecation at least a quarter of the time.
    The above criteria are only applicable for SBMs, i.e., BMs not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema. Subjects who never have SBMs are considered to be constipated and are eligible for the study.
    4. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
    5. Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with ICH GCP Guideline E6 and applicable regulations, before completing any study related procedures.
    6. Subject agrees to stop their current laxative treatment and is willing to use rescue medication as specified in the protocol.
    E.4Principal exclusion criteria
    Subjects are excluded from the study if any of the following exclusion criteria are met.
    1. Subjects in whom constipation is thought to be drug-induced.
    2. Body mass index >37.0kg/m².
    3. Subjects suffering from secondary causes of chronic constipation, such as.
    – Endocrine disorders, e.g. hypopituitarism, hypothyroidism, hypercalcemia, pseudo hypoparathyroidism, pheochromocytoma or glucagon-producing tumors, unless these are controlled by appropriate medical therapy;
    – Metabolic disorders, e.g. porphyria, uremia, hypokaliemia or amyloid neuropathy, unless these are controlled by appropriate medical therapy;
    – Neurological disorders, e.g. Parkinson’s disease, cerebral tumors, cerebrovascular accidents, multiple sclerosis, meningocele, aganglionosis, hypoganglionosis, hyper-ganglionosis, autonomic neuropathy or neuropathy due to chemotherapy, spinal cord injury, Chaga’s disease, or major depression;
    – Surgery.
    Note: if a subject was having chronic constipation prior to the onset of a condition listed above and the constipation has not been worsened by this condition, the subject is eligible for screening; however, if the constipation has started after the onset of 1 of the above conditions and the relation between both cannot be excluded (i.e. it is not certain whether it is secondary to it or not), or when the constipation has worsened after the onset of 1 of the above conditions, the subject is not allowed to be screened for this study.
    4. Subjects with insulin-dependent diabetes mellitus, irrespective of whether the constipation started prior to or after the onset of diabetes.
    5. Rectal evacuation disorder/outlet obstruction. If data are not available regarding rectal evacuation disorder/outlet obstruction, a clinical evaluation should be performed at screening.
    6. Subjects with intestinal perforation or obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory conditions of the intestinal tract, such as Crohn’s disease, ulcerative colitis, or toxic megacolon/megarectum.
    When polyps, cancer, stricture, or other structural or organic disease are found at the endoscopic examination in conjunction with the manometry catheter placement or if it is clinically indicated that a repeat colonoscopy/sigmoidoscopy is needed to rule out or treat such abnormalities, the subject should be a screen failure.
    7. Severe renal impairment (calculated creatinine clearance <30mL/min) or requiring dialysis.
    8. Subjects with clinically significant abnormalities at the physical examination, or in hematology and biochemistry tests performed at the Screening Visit, as judged by the Investigator.
    9. Subjects with a history of alcohol or drug abuse in the previous 6 months, or a positive screen for alcohol or drugs of abuse.
    10. Use of another investigational product (or active enrollment in another drug or vaccine clinical study) within 30 days prior to receiving the first dose of investigational product within this study.
    11. Substantial changes in eating habits within 30 days prior to receiving the first dose of investigational product, as assessed by the Investigator.
    12. An inability to follow a standardized diet and meal schedule, including consumption of clear liquids and a low fat meal, as required during the study.
    13. Prior screen failure, randomization, or enrollment in this study.
    14. Subjects with clinically significant cardiac, vascular, liver, pulmonary, endocrine, neurological, or psychiatric disorders (as evaluated by the Investigator), or metabolic disturbances.
    15. Subjects with any condition that, in the opinion of the Investigator, would complicate or compromise the study or the well-being of the subject or evidence of clinically relevant pathology that could interfere with the study results or put the subject’s safety at risk.
    16. Subjects with lactose intolerance for whom it is expected that low doses of lactose can lead to diarrhea or a known allergy to ingredients or excipients of the investigational products.
    E.5 End points
    E.5.1Primary end point(s)
    • The number of HAPCs during the 12 hours after treatment initiation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12-hour period following AM dosing.
    E.5.2Secondary end point(s)
    • The area under the curve of all HAPCs during the 12 hours after treatment initiation
    • The mean amplitude of HAPC (mmHg), duration (s), and propagation velocity (cm/s)
    • Motility index (number of antro- vs. retro-grade complete propagating waves)
    • Number and consistency of bowel movements on Day 1 as assessed by the Bristol Stool Scale
    • Time between occurrence of BM and last HAPC preceding that BM
    • Time to first HAPC and time to first BM after intake of investigational product on Day 1
    • Time to catheter expulsion for those subjects that expel the catheter prematurely.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12-hour period following AM dosing
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Reader Blind
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Belgium
    United Kingdom
    United States
    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 years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months9
    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: 12
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 12
    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 Decision2012-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-27
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