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

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.

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Key information

Conditions

IBS

Age range

60 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mexiletine

Drug

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Effects of Mexiletine on Colonic Transit in a Patient With a Known SCN5A A997T Mutation

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Oct 30, 2012
Registry last updated: Oct 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed