<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/NCT04423588</url>
  </required_header>
  <id_info>
    <org_study_id>2019-02326</org_study_id>
    <nct_id>NCT04423588</nct_id>
  </id_info>
  <brief_title>Dexlansoprazole Absorption and Marginal Ulceration After Gastric Bypass</brief_title>
  <official_title>Prospective, Monocentric Study of Dexlansoprazole Absorption Preoperative and 6 and 12 Months After Proximal Roux-en-Y Gastric Bypass Surgery and of the Incidence of Marginal Ulcers 6 and 12 Months After Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spital Limmattal Schlieren</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spital Limmattal Schlieren</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Switzerland, the most commonly performed bariatric procedure is the proximal Roux-en-y&#xD;
      gastric Bypass surgery. Since marginal ulceration is a known complication after this&#xD;
      Operation, a Proton pump Inhibitor (PPI) prophylaxis is prescribed postoperatively. Bariatric&#xD;
      surgery may have an impact on the absorption and consequently on the efficacy of drugs. There&#xD;
      are only very little data on the pharmacokinetics of PPIs following PRYGB.&#xD;
&#xD;
      The aim of this study is to analyze the serum concentration of dexlansoprazole preoperative&#xD;
      and after PRYGB surgery in patients taking PPI prophylaxis and to examine the incidence of&#xD;
      marginal ulcers postoperatively in the same population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, monocentric study includes 30 patients undergoing a proximal Roux-en-Y&#xD;
      gastric Bypass surgery and receiving 6 months of postoperative PPI prophylaxis with Dexilant&#xD;
      (dexlansoprazole). The aim is to examine if the LPRYGB has an impact on the absorption of&#xD;
      dexlansoprazole. Peripheral blood samples from the study participants are obtained at fixed&#xD;
      time points after oral Administration of a capsule Dexilant preoperatively as well as 3 and 6&#xD;
      months after surgery. The incidence of marginal ulceration in the same patient population is&#xD;
      assessed by upper endoscopy 6 and 12 months after surgery. The surgery, the PPI prophylaxis&#xD;
      and the upper endoscopy 12 months post-surgery aren't for study purpose. Data collection is&#xD;
      made by measuring serum drug concentration, patient questionnaires, pill count and upper&#xD;
      endoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants enrolled.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 1, 2022</start_date>
  <completion_date type="Anticipated">September 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of dexlansoprazole Serum concentration</measure>
    <time_frame>3 months</time_frame>
    <description>Determination of the dexlansoprazole concentration (ng/ml) in the participants blood at time 0, 60, 90, 120, 210, 300 min after having swallowed a Dosis of dexilant preoperatively and 3 months after surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of dexlansoprazole Serum concentration</measure>
    <time_frame>6 months</time_frame>
    <description>Determination of the dexlansoprazole concentration (ng/ml) in the participants blood at time 0, 60, 90, 120, 210, 300 min after having swallowed a Dosis of dexilant preoperatively and 6 months after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Marginal ulceration</measure>
    <time_frame>6 months</time_frame>
    <description>Study of the incidence of marginal ulcers in the participants 6 months after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Marginal ulceration</measure>
    <time_frame>12 months</time_frame>
    <description>Study of the incidence of marginal ulcers in the participants 12 months after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Marginal ulceration</measure>
    <time_frame>6 months</time_frame>
    <description>Study of the incidence of marginal ulcers in participants undergoing a upper endoscopy in the presence of symptoms Prior to the end of the 6 post-operative months</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Bariatric Surgery</condition>
  <arm_group>
    <arm_group_label>Dexlansoprazole</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The PPI Dexilant (active substance: dexlansoprazole) is administered to the study participants in a prophylactic Regimen for 6 months after the PRYGB-surgery. This drug is already approved by Swissmedic and on the markets in Switzerland. The dosage is 1 capsule 60 mg per os daily in the morning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>dexlansoprazole serum concentration</intervention_name>
    <description>6 blood samples are collected at fixed time Points after oral Administration of 1 dose of dexilant at regular patients visits preoperatively and 3 and 6 months post-surgery.</description>
    <arm_group_label>Dexlansoprazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>upper endoscopy</intervention_name>
    <description>6 and 12 months after surgery the occurrence of marginal ulcers in the same Patient Group is examined by upper endoscopy. The 12-month endoscopy is part of the Routine postoperative diagnosis, the 6-month endoscopy is for study purpose.</description>
    <arm_group_label>Dexlansoprazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent for study and surgery as documented by signature&#xD;
&#xD;
          -  Male and Female Patients over 18 years old eligible for bariatric surgery at the&#xD;
             Department of General Surgery, Limmattal Hospital, according to criteria of the Swiss&#xD;
             Study Group for Morbid Obesity (SMOB) and international Guidelines&#xD;
&#xD;
          -  BMI ≥ 35&#xD;
&#xD;
          -  Failure of conservative Treatment for 2 years&#xD;
&#xD;
          -  Type of surgery: LPRYGB&#xD;
&#xD;
          -  Helicobacter pylori negative&#xD;
&#xD;
          -  Smoker (≥ 1 cigarette daily)&#xD;
&#xD;
          -  Women in reproductive Age: negative pregnancy test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication for a bariatric surgery according to SMOB-criteria&#xD;
&#xD;
          -  Contraindication for PPIs&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Pre- or intraoperative decision for other type of surgery than LPRYGB&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Chronic liver disease Child-Pugh B or C&#xD;
&#xD;
          -  Abuse of drugs or alcohol&#xD;
&#xD;
          -  Suspect of non-compliance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urs Zingg, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chefarzt Chirurgie, Limmattal Hospital</affiliation>
  </overall_official>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>February 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>January 17, 2022</last_update_submitted>
  <last_update_submitted_qc>January 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spital Limmattal Schlieren</investigator_affiliation>
    <investigator_full_name>Prof Urs Zingg</investigator_full_name>
    <investigator_title>Prof. Dr. med. Urs Zingg</investigator_title>
  </responsible_party>
  <keyword>Proton Pump Inhibitor</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexlansoprazole</mesh_term>
    <mesh_term>Lansoprazole</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04423588
org study id: 2019-02326
nct id: NCT04423588
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In Switzerland, the most commonly performed bariatric procedure is the proximal Roux-en-y
      gastric Bypass surgery. Since marginal ulceration is a known complication after this
      Operation, a Proton pump Inhibitor (PPI) prophylaxis is prescribed postoperatively. Bariatric
      surgery may have an impact on the absorption and consequently on the efficacy of drugs. There
      are only very little data on the pharmacokinetics of PPIs following PRYGB.

      The aim of this study is to analyze the serum concentration of dexlansoprazole preoperative
      and after PRYGB surgery in patients taking PPI prophylaxis and to examine the incidence of
      marginal ulcers postoperatively in the same population.
This prospective, monocentric study includes 30 patients undergoing a proximal Roux-en-Y
      gastric Bypass surgery and receiving 6 months of postoperative PPI prophylaxis with Dexilant
      (dexlansoprazole). The aim is to examine if the LPRYGB has an impact on the absorption of
      dexlansoprazole. Peripheral blood samples from the study participants are obtained at fixed
      time points after oral Administration of a capsule Dexilant preoperatively as well as 3 and 6
      months after surgery. The incidence of marginal ulceration in the same patient population is
      assessed by upper endoscopy 6 and 12 months after surgery. The surgery, the PPI prophylaxis
      and the upper endoscopy 12 months post-surgery aren't for study purpose. Data collection is
      made by measuring serum drug concentration, patient questionnaires, pill count and upper
      endoscopy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of dexlansoprazole Serum concentration
time frame: 3 months
description: Determination of the dexlansoprazole concentration (ng/ml) in the participants blood at time 0, 60, 90, 120, 210, 300 min after having swallowed a Dosis of dexilant preoperatively and 3 months after surgery
measure: Change of dexlansoprazole Serum concentration
time frame: 6 months
description: Determination of the dexlansoprazole concentration (ng/ml) in the participants blood at time 0, 60, 90, 120, 210, 300 min after having swallowed a Dosis of dexilant preoperatively and 6 months after surgery
measure: Incidence of Marginal ulceration
time frame: 6 months
description: Study of the incidence of marginal ulcers in the participants 6 months after surgery
measure: Incidence of Marginal ulceration
time frame: 12 months
description: Study of the incidence of marginal ulcers in the participants 12 months after surgery
measure: Incidence of Marginal ulceration
time frame: 6 months
description: Study of the incidence of marginal ulcers in participants undergoing a upper endoscopy in the presence of symptoms Prior to the end of the 6 post-operative months
arm group label: Dexlansoprazole
arm group type: Other
description: The PPI Dexilant (active substance: dexlansoprazole) is administered to the study participants in a prophylactic Regimen for 6 months after the PRYGB-surgery. This drug is already approved by Swissmedic and on the markets in Switzerland. The dosage is 1 capsule 60 mg per os daily in the morning.
intervention type: Diagnostic Test
intervention name: dexlansoprazole serum concentration
description: 6 blood samples are collected at fixed time Points after oral Administration of 1 dose of dexilant at regular patients visits preoperatively and 3 and 6 months post-surgery.
arm group label: Dexlansoprazole
intervention type: Diagnostic Test
intervention name: upper endoscopy
description: 6 and 12 months after surgery the occurrence of marginal ulcers in the same Patient Group is examined by upper endoscopy. The 12-month endoscopy is part of the Routine postoperative diagnosis, the 6-month endoscopy is for study purpose.
arm group label: Dexlansoprazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Urs Zingg, Prof. Dr. med.
role: Principal Investigator
affiliation: Chefarzt Chirurgie, Limmattal Hospital
responsible party type: Principal Investigator
investigator affiliation: Spital Limmattal Schlieren
investigator full name: Prof Urs Zingg
investigator title: Prof. Dr. med. Urs Zingg
mesh term: Dexlansoprazole
mesh term: Lansoprazole