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Effects of Mexiletine on Colonic Transit in a Patient With Irritable Bowel Syndrome - Constipation (IBS-C)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01717404
First Posted: October 30, 2012
Last Update Posted: October 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yuri A. Saito Loftus, Mayo Clinic
  Purpose
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.

Condition Intervention Phase
IBS Drug: Mexiletine Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Mexiletine on Colonic Transit in a Patient With a Known SCN5A A997T Mutation

Resource links provided by NLM:


Further study details as provided by Yuri A. Saito Loftus, Mayo Clinic:

Primary Outcome Measures:
  • change in the 48 hour Colon Transit [ Time Frame: Baseline to 10 days ]
    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.


Enrollment: 1
Study Start Date: October 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mexiletine
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
Drug: Mexiletine
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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Established IBS diagnosis with a known A997T mutation in NaV1.5T

Exclusion Criteria:

  • Normal 48-hour baseline transit study
  • Current use of mexiletine
  • Inability to stay in Rochester for 9 days for testing
  • Known allergy to mexiletine
  • Inability to complete daily diary
  • Taking a medication known to affect myotonia, had a coexisting neuromuscular disease, or had another serious medical illness including second- or third-degree heart block, atrial flutter, atrial fibrillation, ventricular arrhythmia, history of cardiac arrhythmia requiring medication, congestive heart failure, symptomatic cardiomyopathy, or symptomatic coronary artery disease
  • Inability to withdraw medications known to interact with mexiletine. Patient is currently not on any of these medications
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717404


Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Yuri A Saito Loftus, MD, MPH Mayo Clinic
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yuri A. Saito Loftus, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01717404     History of Changes
Other Study ID Numbers: 12-006842
First Submitted: October 18, 2012
First Posted: October 30, 2012
Last Update Posted: October 1, 2013
Last Verified: September 2013

Keywords provided by Yuri A. Saito Loftus, Mayo Clinic:
IBS

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mexiletine
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action