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    Summary
    EudraCT Number:2010-023228-26
    Sponsor's Protocol Code Number:TZP-101-CL-P007
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-16
    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 number2010-023228-26
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Ulimorelin Administered Post-Operatively to Accelerate Recovery of Gastrointestinal (GI) Motility in Subjects Who Have Undergone Partial Bowel Resection
    A.3.2Name or abbreviated title of the trial where available
    Ulysses
    Ulysses
    A.4.1Sponsor's protocol code numberTZP-101-CL-P007
    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 SponsorTRANZYME.INC.
    B.1.3.4CountryUnited States
    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 supportTRANZYME.INC.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPIERREL RESEARCH ITALY SPA
    B.5.2Functional name of contact pointClinical Operation
    B.5.3 Address:
    B.5.3.1Street AddressVIA ALBERTO FALCK, 15
    B.5.3.2Town/ citySESTO SAN GIOVANNI
    B.5.3.3Post code20099
    B.5.3.4CountryItaly
    B.5.4Telephone number0224134223
    B.5.5Fax number0224862961
    B.5.6E-maile.destefani@pierrelgroup.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 No
    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 nameTZP-101 (Ulimorelin)
    D.3.2Product code TZP-101
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTZP-101 hydrochloride monohydrate
    D.3.9.1CAS number 951326-02-6
    D.3.9.2Current sponsor codeTZP-101
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post operative ileus
    Ileo post operatorio
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10054048
    E.1.2Term Postoperative ileus
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    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 and safety of 2 doses of IV ulimorelin in comparison to placebo administered post-operatively to accelerate recovery of GI motility in subjects who have undergone partial bowel resection, thereby reducing the duration of post-operative ileus (POI).
    Valutare rispetto al placebo l’efficacia e la sicurezza della somministrazione postoperatoria di 2 dosaggi di ulimorelin EV per accelerare il recupero della motilita' GI in soggetti sottoposti a resezione parziale dell’intestino, riducendo quindi la durata dell’ileo postoperatorio (POI).
    E.2.2Secondary objectives of the trial
    na
    na
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject is 18 to 80 years of age, inclusive. • Subject is scheduled to undergo open bowel resection with colonic anastomosis. (See Section 11.1 for a list of examples of included and excluded bowel resection surgeries.) • Subject is scheduled to receive post-operative pain management with parenteral opioids (eg, administered IV or intramuscular), but not via thoracic epidural. • Subject is scheduled for the following Enhanced Recovery After Surgery (ERAS) measures:- Nasogastric (NG) tube -Liquids offered on post-operative day 1 (dosing day 2).- Solid food offered on post-operative day 2 (dosing day 3). - Ambulation encouraged on post-operative day 1 (dosing day 2). • Female subjects must be postmenopausal (for at least 1 year and confirmed by serum follicle-stimulating hormone [FSH]), surgically sterile, practicing true sexual abstinence, OR must be using adequate contraception (in the opinion of the investigator) for the duration of the study, including the follow-up period (eg, contraceptive implants, injectables, oral contraceptives, some intrauterine devices [IUD], and/or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository). • Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and, if changed, alternative methods should be used as directed by the investigator throughout the duration of the study. • Females of childbearing potential must have a negative pregnancy test at screening and admission (human chorionic gonadotropin [β-hCG]).After surgery and prior to administration of the first dose of study drug, the following eligibility criteria must be assessed: Inclusion: • Subject underwent open bowel resection with colonic anastomosis
    • Il soggetto ha un’eta' compresa fra i 18 e gli 80 anni, compresi gli estremi dell’intervallo. • Per il soggetto e' in programma una resezione dell’intestino in chirurgia open con anastomosi del colon. (si veda la Sezione 11.1 per un elenco di esempio di interventi di resezione intestinale compresi ed esclusi) • Per il soggetto e' in programma una gestione postoperatoria del dolore con oppioidi per via parenterale (p. es. in somministrazione EV o intramuscolare), ma non per via epidurale toracica. • Per il soggetto sono in programma le seguenti misure di miglioramento del decorso postoperatorio (Enhanced Recovery After Surgery, ERAS): o rimozione del tubo nasogastrico (NG) al termine della chirurgia/anestesia. o offerta di liquidi nel giorno 1 post operatorio (giorno 2 di somministrazione). o offerta di cibo solido nel giorno 2 postoperatorio (giorno 3 di somministrazione). o Incoraggiamento della deambulazione nel giorno 1 postoperatorio (giorno 2 di somministrazione). • I soggetti di sesso femminile devono essere in postmenopausa (per almeno 1 anno e con conferma per il livello di ormone follicolo stimolante [FSH]), chirurgicamente sterili, praticanti una reale astinenza sessuale, OPPURE devono usare una contraccezione adeguata (a giudizio dello sperimentatore) per tutta la durata dello studio, compreso il periodo di follow-up (p. es. impianto contraccettivo, contraccettivi iniettabili, orali, alcuni dispositivi intrauterini [IUD], e/o metodi barriera (preservativo o diaframma cervicale) assieme a schiuma/gel/crema/ovuli spermicidi). • I metodi anticoncezionali ormonali e i dispositivi intrauterini devono essere a regime per un periodo di 3 mesi prima del dosaggio e, se dovessero essere variati, si dovra' usare un metodo alternativo, seguendo le indicazioni dello sperimentatore, per tutta la durata dello studio. • Le donne potenzialmente in grado di avere figli devono presentare un risultato negativo al test di gravidanza allo screening e al momento del ricovero (gonadotropina corionica umana [B-hCG]).Dopo l’intervento e prima della somministrazione della prima dose del farmaco di studio, devono essere accertati i seguenti criteri di eleggibilita': Inclusione: -Il soggetto e' stato sottoposto a resezione chirurgica in open dell’intestino con anastomosi del colon
    E.4Principal exclusion criteria
    Subject weighs more than 200kg (441 pounds). • Subject is classified as American Society of Anesthesiologists (ASA) Class 4, 5, or 6 (See Section 11.2). • Subject has complete bowel obstruction. • Subject is scheduled to receive total colectomy. • Subject is scheduled to receive a low rectal or anal anastomosis (eg, proctectomy, ileoanal anastomosis). • Subject is scheduled to receive a stoma (eg, ileostomy, jejunostomy, colostomy). • Subject is scheduled for laparoscopic or laparoscopic hand-assisted procedure. • Subject is scheduled to receive prophylactic anti-emetics post surgery; however subjects may receive intraoperative anti-emetics as part of the anesthesia protocol. • Subject is scheduled to receive a thoracic epidural for anesthesia or analgesia. • Subject’s surgical procedure is considered to be an emergency procedure. • Subject is scheduled to receive ENTEREG/alvimopam or any other peripheral opioid antagonist such as RELISTOR/methylnaltrexone bromide. • Subject has significant impairment of liver or renal function (alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) 2.5 times the upper limit of normal; creatinine clearance <30mL/minute (min), estimated using serum creatinine with the formula [(140 - age in years) × weight in kg]/[(72 × serum creatinine in mg/dl) × 0.85 for female subjects]. • Subject is anticipated to require prolonged post-operative ventilation. • Subject has a psychiatric disorder or cognitive impairment that, in the opinion of the Investigator, would interfere with participation in the study. • Subject has participated in an investigational study 30 days prior to the study initiation. • Subject has a positive laboratory test result for controlled substances (other than forthose prescribed by a medical professional and/or accounted for by concomitant medications) at screening. • Subject is known to have Hepatitis B or Hepatitis C infection currently associated with clinically significant symptoms or abnormal liver function.Subject has a recent, adult history of clinically significant hypersensitivity reaction(s) to any drug, in the opinion of the Investigator. • Subject is pregnant (confirmed by serum pregnancy test) or is breastfeeding. • Subject has known history of drug or alcohol abuse within the previous year.After surgery and prior to administration of the first dose of study drug, the following eligibility criteria must be assessed:Subject has complete bowel obstruction. • Subject received a total colectomy. • Subject received a low rectal or an anal anastomosis (eg proctectomy or ileoanal anastomosis). • Subject received a stoma (eg, jejunostomy, ileostomy, colostomy). • Subject underwent a laparoscopic procedure (including a hand-assisted laparoscopic procedure). • Subject received a thoracic epidural for anesthesia or analgesia.
    • Il soggetto pesa piu' di 200kg (441 libbre). • Il soggetto e' stato classificato in classe ASA (American Society of Anesthesiologists) 4, 5 o 6 (si veda la Sezione 11.2). • Il soggetto presenta ostruzione intestinale completa • Il soggetto e' candidato a colectomia totale • Il soggetto e' candidato ad anastomosi del retto basso o anale (p. es. proctectomia, anastomosi ileoanale). • Il soggetto e' candidato a ricevere una stomia (p.es., ileostomia, digiunostomia, colostomia). • Il soggetto e' candidato a procedura laparoscopica o laparoscopica manualmente assistita • Il soggetto e' candidato a ricevere profilassi antiemetica postoperatoria; tuttavia, i soggetti potranno ricevere antiemetici intraoperatori facenti parte del protocollo dell’anestesia. • Il soggetto e' candidato a ricevere epidurale toracica per l’anestesia o l’analgesia. • La procedura chirurgica a cui deve essere sottoposto il soggetto e' ritenuta procedura di emergenza. • Il soggetto e' candidato a ricevere ENTEREG/alvimopam o qualsiasi altro antagonista periferico degli oppioidi quali RELISTOR/metilnaltrexone bromuro. • Il soggetto presenta significativa insufficienza epatica o della funzione renale (alanina transaminasi (ALT)/ aspartato transaminasi (AST) 2.5 volte il limite superiore della norma; • Clearance della creatinina&lt;30mL/minuto (min), stimata mediante creatinina sierica con la formula [(140 – eta' in anni) × peso in kg]/[(72 × creatinina sierica in mg/dl) × 0.85 per i soggetti di sesso femminile]. • Si prevede che il soggetto avra' necessita' di ventilazione postoperatoria prolungata. • Il soggetto presenta disordini psichiatrici o cognitivi tali da interferire, a giudizio dello sperimentatore, con la partecipazione allo studio. •Il soggetto ha partecipato a uno studio sperimentale nei 30 giorni precedenti l’inizio dello studio. •Il soggetto presenta risultato positivo agli esami di laboratorio allo screening per sostanze soggette a controllo (che non siano state prescritte da un operatore sanitario e/o non siano giustificate in quanto medicinali concomitanti). •Il soggetto presenta notoriamente infezione da Epatite B o C attualmente associate a sintomi clinicamente significativi o alterazione della funzione epatica. •Il soggetto ha una storia recente, da adulto, di reazioni di ipersensibilita' clinicamente significative a qualsiasi farmaco, a giudizio dello sperimentatore. •Il soggetto e' in stato di gravidanza (confermato da un test di gravidanza su siero) o sta allattando al seno. •Il soggetto ha una storia nota di abuso di alcol o droghe nell’anno precedente. Dopo l’intervento e prima della somministrazione della prima dose del farmaco di studio, devono essere accertati i seguenti criteri di eleggibilita':• Il soggetto presenta ostruzione intestinale completa • Il soggetto ha ricevuto colectomia totale • Il soggetto ha ricevuto anastomosi del retto basso o anale (p. es. proctectomia, anastomosi ileoanale). • Il soggetto ha ricevuto una stomia (p.es., ileostomia, digiunostomia, colostomia). • Il soggetto e' stato sottoposto a procedura laparoscopica o laparoscopica manualmente assistita • Il soggetto ha ricevuto epidurale toracica per l’anestesia o l’analgesia
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time to recovery of GI function as defined by the time from the end of surgery to GI2, the later of first BM and tolerance of solid food (ie, having finished a meal that required chewing and having experienced no significant nausea/vomiting for 4hr after the meal).
    • L’endpoint primario di efficacia e' il tempo al recupero della funzione GI, definito come tempo intercorso dal termine dell’intervento al GI2, l’ultimo a verificarsi tra il primo MI e la tolleranza al cibo solido (vale a dire, aver finito un pasto che ha richiesto masticazione senza avere nausea/vomito significativi per 4h dopo il pasto). (Nota: si dira' che il soggetto avra' avuto “assenza di nausea/vomito significativi” se non avra' manifestato nuovi EA di nausea o vomito nel corso delle 4h successive al pasto)
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Information not present in EudraCT
    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 trial3
    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 EEA27
    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
    Last patient last visit
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 189
    F.4.2.2In the whole clinical trial 315
    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 Decision2011-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-04
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