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    Summary
    EudraCT Number:2012-005348-92
    Sponsor's Protocol Code Number:PROGASS
    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:2013-01-11
    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 number2012-005348-92
    A.3Full title of the trial
    PROGASS PRucalopride On the GAstreonteric transit in Systemic Sclerosis
    PROGASS Studio per valutare l’effetto della Prucalopride sul transito gastroenterico in pazienti affetti da sclerosi sistemica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PROGASS PRucalopride On the GAstreonteric transit in Systemic Sclerosis
    PROGASS Studio per valutare l’effetto gastroenterico della Prucalopride in pazienti affetti da sclerosi sistemica
    A.3.2Name or abbreviated title of the trial where available
    PROGASS
    PROGASS
    A.4.1Sponsor's protocol code numberPROGASS
    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 SponsorFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
    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 supportShire Italia S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    B.5.2Functional name of contact pointU.O.ALLERGOLOGIA-IMMUNOLOGIA
    B.5.3 Address:
    B.5.3.1Street AddressVIA PACE 9
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number02.55035272
    B.5.5Fax number02.55035289
    B.5.6E-maillorberimm@hotmail.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*28CPR RIV 2MG
    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 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 SUCCINATE
    D.3.9.4EV Substance CodeSUB28850
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    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 Yes
    D.3.11.13.1Other medicinal product typemedicinale di natura chimica
    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
    Sysemic sclerosis with gastroenteric involvement (constipation)
    Sclerosi sistemica con interessamento gastroenterico (stipsi)
    E.1.1.1Medical condition in easily understood language
    Sysemic sclerosis with gastroenteric involvement (constipation)
    Sclerosi sistemica con interessamento gastroenterico (stipsi)
    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 SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Improve sponaneous bovel movements in patients with constipation secondary to systemic sclerosis
    Migliorare i movimenti spontanei intestinali in pazienti affetti da stipsi secondaria a sclerosi sisemica.
    E.2.2Secondary objectives of the trial
    Reduce the frequency and intensity of gasto-esophageal reflux sympoms and the quality of life.
    Ridurre la frequenza e l'intensità dei sintomi da reflusso gastro-esofageo e la qualità della vita.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    SSc diagnosis according to (12)
    - Female gender (not breast-feeding, not pregnant)
    - Age > 18 years
    - Mild-to-moderate symptoms of gastro-esophageal reflux disease on a 4-grade modified Likert scale (grade 1 and 2)
    - Mild-to-severe constipation symptoms on a 5-grade modified Likert scale (grade 1 to 3)
    - Diagnosi di Sclerosi Sistemica in accordo con i criteri ACR (12)
    - Sesso femminile (non in allattamento, non in gravidanza)
    - Età &gt; 18 anni
    - Sintomi da lievi a moderati di reflusso gastroesofageo sulla scala di Likert modificata a 4 punti e stipsi di grado lieve-moderato su una scala di Likert modificata a 5 punti
    - stipsi di grado lieve-moderato su una scala di Likert modificata a 5 punti (punteggio da 1 a 3)
    E.4Principal exclusion criteria
    - Patients enrolled in other clinical trials
    - Current use or recent use (<1 weeks) of prokinetics
    - Current use or recent use (<1 weeks) of laxaitives
    - Severe symptoms (grade 3) of gastro-esophageal reflux disease on a 4-grade modified Likert scale
    - Very severe constipation symptoms (grade 4) on a 5-grade modified Likert scale
    - Renal insufficiency
    - Hepatic insufficiency Child-Pugh class C
    - Inflammatory bowel disease
    - Pazienti arruolati in altri studi clinici
    - Uso in corso o recente (&lt;1 settimana) di procinetici
    - Uso in corso o recente (&lt;1 settimana) di lassativi
    - Sintomi severi (punteggio 3)di malattia da reflusso gastroesofageo sulla scala di Likert modificata a 4 punti
    - Stipsi di grado molto severo (punteggio 4) su una scala di Likert modificata a 5 punti
    - insufficienza renale
    - Insufficienza epatica classe C secondo l’indice di Child-Pugh
    - Malattia infiammatoria intestinale
    E.5 End points
    E.5.1Primary end point(s)
    Reduction in the inesinal transit time as assessed by he lactulose breath test
    Riduzione del tempo di transito intestinale misurato dal test del respiro al lattulosio
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks/pazient
    12 settimane/paziente
    E.5.2Secondary end point(s)
    - Reduction in the time to gastric emptying as assessed by the 13-C octanoic acid breath test
    - Improvement of the quality of life as assessed by the UCLA scleroderma clinical trial gastrointestinal tract instrument, reflux, abdominal distension and constipation subitems
    - Change in the number of spontaneous complete bowel movements (SCBM) per week with respect to baseline.
    - Self-reported efficacy on a 5-point modified Likert scale.
    - Mean number of laxative tablets used as a rescue medication for constipation.
    - Mean number of Gaviscon chewable tablets used as rescue medication for reflux disease
    - Riduzione del tempo di svuotamento gastrico misurato con il test del respiro con acido 13-C ottanoico
    -Miglioramento della qualità della vita misurato con il questionario UCLA SCTC 2.0, item riguardanti il reflusso, la distensione addominale e la stipsi
    - Variazione nel numero di movimenti intestinali spontanei completi (SCBM) alla settimana rispetto al basale.
    - Efficacia soggettiva su una scala modificata secondo Likert a 5 punti.
    - Numero medio di lassativi utilizzati come terapia di supporto per la stipsi.
    - Numero medio di compresse masticabili di Gaviscon come terapia di supporto per il reflusso gastro-esofageo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks/pazient
    12 settimane/paziente
    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 No
    E.6.5Efficacy No
    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 No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    ASSENZA DI FARMACO
    NO DRUG
    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 months12
    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: 40
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-01-11. Yes
    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 state40
    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)
    Standard clinical care
    Pratica clinica abituale
    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 Decision2013-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-19
    P. End of Trial
    P.End of Trial StatusOngoing
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