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    Summary
    EudraCT Number:2009-015719-42
    Sponsor's Protocol Code Number:M0001-C302
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-10
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-015719-42
    A.3Full title of the trial
    A 12-week, randomised, double-blind, placebo controlled trial to evaluate the efficacy, quality of life, safety and tolerability of prucalopride in male subjects with chronic constipation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy, quality of life, side effects and tolerability of long term treatment (12 weeks) with prucalopride in male patients aged ≥18 years with chronic constipation
    A.4.1Sponsor's protocol code numberM0001-C302
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01147926
    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 NV
    B.5.2Functional name of contact pointShire-Movetis Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressVeedijk 58
    B.5.3.2Town/ cityTurnhout
    B.5.3.3Post code2300
    B.5.3.4CountryBelgium
    B.5.4Telephone number3214 404 390
    B.5.5Fax number3214 404 391
    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
    D.2.1.1.2Name of the Marketing Authorisation holderShire-Movetis NV
    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.3.1Product nameResolor
    D.3.2Product code M0001
    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 INNPRUCALOPRIDE
    D.3.9.1CAS number 179474818
    D.3.9.2Current sponsor codeM0001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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
    D.2.1.1.2Name of the Marketing Authorisation holderShire-Movetis NV
    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.3.1Product nameResolor
    D.3.2Product code M0001
    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 INNPRUCALOPRIDE
    D.3.9.1CAS number 179474818
    D.3.9.2Current sponsor codeM001
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Chronic constipation
    E.1.1.1Medical condition in easily understood language
    Chronic constipation
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10063582
    E.1.2Term Constipation chronic
    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
    To evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation
    E.2.2Secondary objectives of the trial
    To evaluate the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main inclusion criteria to be assessed at screening:
    1. Subject is a male out-patient ≥18 years of age (no upper age limit).
    2. Subject has a history of constipation, i.e. reports an average of ≤2 spontaneous bowel movements (SBM)/week that result in a feeling of complete evacuation (SCBM) and one or more of the following for at least 6 months before the selection visit:
    a) Very hard (little balls) and/or hard stools for at least a quarter of the stools;
    b) Sensation of incomplete evacuation following for at least a quarter of stools;
    c) Straining at defecation for 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 trial.
    3. Subject agrees to stop his current laxative treatment and is willing to use rescue.

    Main inclusion criteria to be assessed at baseline (randomisation):
    1. During the run-in period, the subject reports an average of ≤2 SBM/week that result in a feeling of complete evacuation (SCBM).* This includes subjects who never have SBMs.
    2. Subject stopped his/her laxative treatment and did not use rescue mediation on more than 75% of days during the run-in period.* medication according to the rescue rule [Dulcolax® (bisacodyl)/ enemas].
    3. Subject did not use disallowed medication during the run-in period.
    * Excluding the first 7 days for subjects using medication influencing bowel habit or excluding the days between screening and the 7 days following the colonoscopy/sigmoidoscopy for those who had a colonoscopy/sigmoidoscopy after screening.
    E.4Principal exclusion criteria
    1. Subjects in whom constipation is thought to be drug-induced.
    2. Subjects using any disallowed medication.
    3. Subjects suffering from secondary causes of chronic constipation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary parameter is the proportion (%) of subjects with an average of ≥3 SCBMs/week (i.e. a responder) over the 12-week double-blind treatment period.
    If e-diary data are available for less than 28 days, the subject will be considered a non-responder for the primary analysis.
    The Cochran-Mantel-Haenszel test controlling for the randomisation stratification factors (country and CBM) will be used to compare treatment groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The key evaluation period will be the 24-week double-blind treatment phase. This endpoint will also be evaluated in periods of 4 weeks and per week of treatment
    E.5.2Secondary end point(s)
    A:
    • Proportion (%) of subjects with an average increase of ≥1 (SC)BM/week compared to the run-in period, over the entire treatment period
    • The average number of (SC)BM/week and change from baseline
    • Number of (SC)BMs per week: descriptive statistics and distribution in categories as 0, (0;1), [1;2), [2;3), [3;->)
    • Consistency per (SC)BM: descriptive statistics of 7-point score and % (SC)BM with normal consistency (Type 3 or 4 on the Bristol stool scale)
    • Straining per (SC)BM: descriptive statistics of 5-point score and % (SC)BM with no straining and with severe/very severe straining
    • The proportion (%) of subjects with ≥3 (SC)BM/week and with ≥50% of (SC)BM with Type 3 or 4 on the Bristol stool scale and mild or moderate straining
    • Sensation of complete evacuation per (S)BM: % (S)BM with sensation of complete evacuation
    • Average time to first (SC)BM after the first intake of the trial medication (Day 1) and after the intake on Day 29 (Week 4)
    • Average number of bisacodyl (Dulcolax®) tablets taken per week and the average number of days with bisacodyl (Dulcolax®) use per week
    B:
    • Subject’s global assessment on severity of constipation (5-point scales; 0=none, 4=very severe)
    • Subject’s global assessment on efficacy of treatment (5-point scales; 0=none, 4=extremely effective)
    • Subject’s lower GI symptom assessment by the PAC-SYM total score, subscale scores (stool symptoms, abdominal symptoms and rectal symptoms) and individual item scores (5 point scales; 0=none, 4=very severe)
    E.5.2.1Timepoint(s) of evaluation of this end point
    A number of secondary parameters will be derived from the e-diary and evaluated over similar periods. The primary parameter and the below secondary parameters in Category A will be evaluated over 12-week and 4 week periods, and per individual week of treatment.
    Secondary parameters in category B will be summarised per scheduled visits and endpoint (last observation carried forward, LOCF), for both observed values and changes from baseline.
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 EEA73
    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
    As per protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial 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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 334
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    F.2 Gender
    F.2.1Female No
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 348
    F.4.2.2In the whole clinical trial 348
    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)
    routine treatment
    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 Decision2010-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-17
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