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    Summary
    EudraCT Number:2010-023229-38
    Sponsor's Protocol Code Number:TZP-101-CL-P008
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-11-24
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-023229-38
    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.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this clinical study is to determine if ulimorelin can, safely,
    accelerate the recovery of bowel activity following partial bowel
    resection surgery and reduce bowel inactivity.
    A.3.2Name or abbreviated title of the trial where available
    ULISES
    A.4.1Sponsor's protocol code numberTZP-101-CL-P008
    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.4.1Name of organisation providing supportNorgine Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNorgine Ltd
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressNorgine House, Widewater Place, Moorhall Rd,
    B.5.3.2Town/ cityHarefield, Uxbridge
    B.5.3.3Post codeUB9 6NS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441895453652
    B.5.5Fax number00441895453729
    B.5.6E-mailcpediconi@norgine.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) concentrate for solution for infusion
    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 INNulimorelin hydrocholoride monohydrate
    D.3.9.2Current sponsor codeTZP-101 hydrochloride monohydrate
    D.3.9.3Other descriptive nameUlimorelin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 Yes
    D.3.11.13.1Other medicinal product typeghrelin receiptor agonist
    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 in subjects who have undergone partial bowel resection
    E.1.1.1Medical condition in easily understood language
    The period of little or no activity in the bowels (intestines) (sometimes called "post-operative ileus") in subjects who have undergone partial bowel resection surgery
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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)
    E.2.2Secondary objectives of the trial
    No secondary objectives
    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:
    o Nasogastric (NG) tube removed at the end of surgery/anesthesia.
    o Liquids offered on post-operative day 1 (dosing day 2).
    o Solid food offered on post-operative day 2 (dosing day 3).
    o 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 [beta-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
    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 for those 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:
    Exclusion:
    • 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.
    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).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time to reach GI2 is the primary endpoint.

    There will be a twice-daily review of clinical milestones (including
    primary endpoint) until discharge.

    Daily infusions of ulimorelin will continue until one of the following
    occurs:
    1. GI2 (the later of first BM and tolerance of solid food).
    2. Hospital discharge.
    3. 7 days of treatment with study drug.
    E.5.2Secondary end point(s)
    • Time from the end of surgery to first BM
    • GI2 by 72hr post surgery with no AE of "ileus*", as defined per
    protocol, during the index admission, ie, the original admission for surgery ("responder" endpoint)
    • Time to "met discharge criteria" defined as meeting all of the following criteria: effective transit of intestinal contents (ie, had BM or flatus); tolerance of oral intake (ie, tolerance of 2 solid meals); analgesia consistent with discharge status (eg, adequate oral analgesia) and medically stable for discharge (eg, hospitalization is not required for treatment of a medical condition such as pneumonia, sepsis etc.)
    • GI2 by 72hr post surgery
    • Vomiting reported as an AE
    • Nausea reported as an AE
    • Ileus* reported as an AE
    • Time to "Discharge Order Written"
    • NG tube reinsertion
    • Failure to reach GI2 by end of Day 5 (120hr post surgery)
    • Time to discharge from the hospital
    * For the purposes of this study, any AE of " ileus"(including "prolonged" and "paralytic" ileus etc.) needs to meet the following definition: NG tube reinsertion and/or "down-grading" of permitted oral intake to "NPO" (nothing by mouth), unless bowel obstruction is identified radiologically or at subsequent surgery.
    E.5.2.1Timepoint(s) of evaluation of this end point
    There will be a twice-daily review of clinical milestones (including
    primary endpoint) until discharge.
    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 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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Bulgaria
    Czech Republic
    France
    Germany
    Romania
    Serbia
    Spain
    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
    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 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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 88
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 218
    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)
    Normal treatment expected after subject has ended his/her participation in the trial.
    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 Decision2012-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-02
    P. End of Trial
    P.End of Trial StatusOngoing
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