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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:
Information provided by (Responsible Party):
Yuri A. Saito Loftus, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01717404
First received: October 18, 2012
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • change in the 48 hour Colon Transit [ Time Frame: Baseline to 10 days ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   60 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717404

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

No publications provided

Responsible Party: Yuri A. Saito Loftus, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01717404     History of Changes
Other Study ID Numbers: 12-006842
Study First Received: October 18, 2012
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013