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

Phase 1

Completed

• Conditions: IBS
• Interventions: Drug: Mexiletine

• Registration Number: NCT01717404
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mexiletine	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

Primary Outcome Measures

Name	Time	Method
change in the 48 hour Colon Transit	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.