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

IBS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01717404
• Other study ID #: 12-006842
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2012
• Last updated: September 30, 2013
• Start date: October 2012
• Est. completion date: November 2012

Study information

• Verified date: September 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• IBS

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the 48 hour Colon Transit	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.	Baseline to 10 days	Yes