<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01710982</url>
  </required_header>
  <id_info>
    <org_study_id>NPJ5004-04/2011 (SDS)</org_study_id>
    <nct_id>NCT01710982</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety of TZP-101 (IV Ulimorelin) Administered Post-Operatively in Patients Who Have Undergone Partial Bowel Resection</brief_title>
  <official_title>A Multicentre, Randomised, Double-blind, Placebo-Controlled Study to Evaluate the Safety of TZP-101 (IV Ulimorelin) Administered Post-Operatively in Patients Who Have Undergone Partial Bowel Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norgine</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norgine</source>
  <brief_summary>
    <textblock>
      A study to evaluate the safety of TZP-101 in comparison with placebo when administered&#xD;
      post-operatively in patients who have undergone partial bowel resection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>32 days post-dosing</time_frame>
    <description>To evaluate the safety of TZP-101 in comparison with placebo when administered post-operatively in patients who have undergone partial bowel resection.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Postoperative Ileus</condition>
  <arm_group>
    <arm_group_label>TZP-101</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TZP-101</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TZP-101</intervention_name>
    <arm_group_label>TZP-101</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is 18 to 80 years of age, inclusive.&#xD;
&#xD;
          -  Patient is scheduled to undergo open bowel resection.&#xD;
&#xD;
          -  Female patients must be postmenopausal (for at least 1 year), surgically sterile,&#xD;
             practicing true sexual abstinence, OR must be using adequate contraception (in the&#xD;
             opinion of the investigator) for the duration of the study, including the follow-up&#xD;
             period (e.g. contraceptive implants, injectables, oral contraceptives, some&#xD;
             intrauterine devices [IUD], and/or barrier method (condom or occlusive cap) with&#xD;
             spermicidal foam/gel/film/cream/suppository).&#xD;
&#xD;
          -  Hormonal and IUD methods of contraception must be established for a period of 3 months&#xD;
             prior to dosing and, if changed, alternative methods should be used as directed by the&#xD;
             investigator throughout the duration of the study.&#xD;
&#xD;
          -  Females of childbearing potential must have a negative pregnancy test at screening and&#xD;
             admission&#xD;
&#xD;
        After surgery and prior to administration of the first dose of study drug, the following&#xD;
        eligibility criteria must be assessed:&#xD;
&#xD;
          -  Patient underwent open bowel resection.&#xD;
&#xD;
          -  Patient has given written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient weighs more than 200kg (441 pounds).&#xD;
&#xD;
          -  Patient is classified as American Society of Anesthesiologists (ASA) Class 4, 5, or 6&#xD;
&#xD;
          -  Patient has complete bowel obstruction.&#xD;
&#xD;
          -  Patient is scheduled to receive a low rectal or anal anastomosis (e.g. proctectomy or&#xD;
             ileoanal anastomosis) (low rectal is defined as below the anterior peritoneal&#xD;
             reflection - typically 9-10cm from the anal verge).&#xD;
&#xD;
          -  Patient is scheduled for laparoscopic or laparoscopic hand-assisted procedure.&#xD;
&#xD;
          -  Patient's surgical procedure is considered to be an emergency procedure.&#xD;
&#xD;
          -  Patient has significant impairment of liver or renal function (alanine&#xD;
             aminotransferase (ALT)/ aspartate aminotransferase (AST) 2.5 times the upper limit of&#xD;
             normal; creatinine clearance &lt;30mL/minute (min), estimated using serum creatinine with&#xD;
             the formula [(140 - age in years) × weight in kg]/[(72 × serum creatinine in mg/dl) ×&#xD;
             0.85 for female patients].&#xD;
&#xD;
          -  Patient is anticipated to require prolonged post-operative ventilation.&#xD;
&#xD;
          -  Patient has a psychiatric disorder or cognitive impairment that, in the opinion of the&#xD;
             Investigator, would interfere with participation in the study.&#xD;
&#xD;
          -  Patient has participated in an investigational drug study 30 days prior to the study&#xD;
             initiation.&#xD;
&#xD;
          -  Patient has a positive laboratory test result for controlled substances (other than&#xD;
             for those prescribed by a medical professional and/or accounted for by concomitant&#xD;
             medications) at screening.&#xD;
&#xD;
          -  Patient is known to have Hepatitis B or Hepatitis C infection currently associated&#xD;
             with clinically significant symptoms or abnormal liver function.&#xD;
&#xD;
          -  Patient has a recent, adult history of clinically significant hypersensitivity&#xD;
             reaction(s) to any drug, in the opinion of the Investigator.&#xD;
&#xD;
          -  Patient is pregnant (confirmed by pregnancy test) or is breastfeeding.&#xD;
&#xD;
          -  Patient has known history of drug or alcohol abuse within the previous year.&#xD;
&#xD;
        After surgery and prior to administration of the first dose of study drug, the following&#xD;
        eligibility criteria must be assessed:&#xD;
&#xD;
          -  Patient received a low rectal or an anal anastomosis (e.g. proctectomy or ileoanal&#xD;
             anastomosis) (low rectal is defined as below the anterior peritoneal reflection -&#xD;
             typically 9-10cm from the anal verge).&#xD;
&#xD;
          -  Patient underwent a laparoscopic procedure (including a hand-assisted laparoscopic&#xD;
             procedure).&#xD;
&#xD;
          -  Patient is classified as American Society of Anesthesiologists (ASA) Class 4, 5, or 6.&#xD;
&#xD;
          -  Patients has received ulimorelin previously&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandy Eisen, MD</last_name>
    <role>Study Director</role>
    <affiliation>Norgine Ltd</affiliation>
  </overall_official>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>October 17, 2012</last_update_submitted>
  <last_update_submitted_qc>October 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01710982
org study id: NPJ5004-04/2011 (SDS)
nct id: NCT01710982
lead sponsor: 
A study to evaluate the safety of TZP-101 in comparison with placebo when administered
      post-operatively in patients who have undergone partial bowel resection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants with Treatment Emergent Adverse Events as a Measure of Safety and Tolerability
time frame: 32 days post-dosing
description: To evaluate the safety of TZP-101 in comparison with placebo when administered post-operatively in patients who have undergone partial bowel resection.
arm group label: TZP-101
arm group type: Active Comparator
description: TZP-101
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: TZP-101
arm group label: TZP-101
intervention type: Other
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sandy Eisen, MD
role: Study Director
affiliation: Norgine Ltd
responsible party type: Sponsor