<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/NCT01717404</url>
  </required_header>
  <id_info>
    <org_study_id>12-006842</org_study_id>
    <nct_id>NCT01717404</nct_id>
  </id_info>
  <brief_title>Effects of Mexiletine on Colonic Transit in a Patient With Irritable Bowel Syndrome - Constipation (IBS-C)</brief_title>
  <official_title>Effects of Mexiletine on Colonic Transit in a Patient With a Known SCN5A A997T Mutation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To understand if Mexiletine will restores normal colonic motility in a patient with irritable&#xD;
      bowel syndrome - constipation (IBS-C) and a genetic mutation in SCN5A.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To understand if Mexiletine will restore normal colonic motility in a patient with a missense&#xD;
      mutation in SCN5A, which encodes a voltage-sensitive sodium channel NaV1.5 as it is known to&#xD;
      rescue certain expression defects of NaV1.5 in vitro.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 1</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 in the 48 hour Colon Transit</measure>
    <time_frame>Baseline to 10 days</time_frame>
    <description>Colon transit will be measured using validated scintigraphy methods conducted in our Clinical Research Unit (CRU).[17, 18] The participant will ingest a Tc-99m labeled sulfur colloid in egg to be used as a stomach marker and ln-111 chloride bound to activated charcoal enclosed in a methacrylate-coated capsule to measure colonic transit.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>IBS</condition>
  <arm_group>
    <arm_group_label>Mexiletine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6-day treatment period during which the medication will be taken orally with an initial dose of: 200 mg every 8 hours for 3 doses on day 3, increasing to 300 mg every 8 hours on days 4 and 5 (6 doses), and increasing further to 400 mg every 8 hours on days 6-8 if no telemetry changes and no dose limiting side effects</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mexiletine</intervention_name>
    <description>6-day treatment period during which the medication will be taken orally with an initial dose of: 200 mg every 8 hours for 3 doses on day 3, increasing to 300 mg every 8 hours on days 4 and 5 (6 doses), and increasing further to 400 mg every 8 hours on days 6-8 if no telemetry changes and no dose limiting side effects</description>
    <arm_group_label>Mexiletine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Established IBS diagnosis with a known A997T mutation in NaV1.5T&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Normal 48-hour baseline transit study&#xD;
&#xD;
          -  Current use of mexiletine&#xD;
&#xD;
          -  Inability to stay in Rochester for 9 days for testing&#xD;
&#xD;
          -  Known allergy to mexiletine&#xD;
&#xD;
          -  Inability to complete daily diary&#xD;
&#xD;
          -  Taking a medication known to affect myotonia, had a coexisting neuromuscular disease,&#xD;
             or had another serious medical illness including second- or third-degree heart block,&#xD;
             atrial flutter, atrial fibrillation, ventricular arrhythmia, history of cardiac&#xD;
             arrhythmia requiring medication, congestive heart failure, symptomatic cardiomyopathy,&#xD;
             or symptomatic coronary artery disease&#xD;
&#xD;
          -  Inability to withdraw medications known to interact with mexiletine. Patient is&#xD;
             currently not on any of these medications&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuri A Saito Loftus, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>September 30, 2013</last_update_submitted>
  <last_update_submitted_qc>September 30, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Yuri A. Saito Loftus</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>IBS</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mexiletine</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/NCT01717404
org study id: 12-006842
nct id: NCT01717404
lead sponsor: 
has dmc: No
To understand if Mexiletine will restores normal colonic motility in a patient with irritable
      bowel syndrome - constipation (IBS-C) and a genetic mutation in SCN5A.
To understand if Mexiletine will restore normal colonic motility in a patient with a missense
      mutation in SCN5A, which encodes a voltage-sensitive sodium channel NaV1.5 as it is known to
      rescue certain expression defects of NaV1.5 in vitro.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in the 48 hour Colon Transit
time frame: Baseline to 10 days
description: Colon transit will be measured using validated scintigraphy methods conducted in our Clinical Research Unit (CRU).[17, 18] The participant will ingest a Tc-99m labeled sulfur colloid in egg to be used as a stomach marker and ln-111 chloride bound to activated charcoal enclosed in a methacrylate-coated capsule to measure colonic transit.
arm group label: Mexiletine
arm group type: Experimental
description: 6-day treatment period during which the medication will be taken orally with an initial dose of: 200 mg every 8 hours for 3 doses on day 3, increasing to 300 mg every 8 hours on days 4 and 5 (6 doses), and increasing further to 400 mg every 8 hours on days 6-8 if no telemetry changes and no dose limiting side effects
intervention type: Drug
intervention name: Mexiletine
description: 6-day treatment period during which the medication will be taken orally with an initial dose of: 200 mg every 8 hours for 3 doses on day 3, increasing to 300 mg every 8 hours on days 4 and 5 (6 doses), and increasing further to 400 mg every 8 hours on days 6-8 if no telemetry changes and no dose limiting side effects
arm group label: Mexiletine
criteria: 
gender: Female
minimum age: 60 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yuri A Saito Loftus, MD, MPH
role: Principal Investigator
affiliation: Mayo Clinic
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Yuri A. Saito Loftus
investigator title: PI
mesh term: Mexiletine