NCT01717404

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 60 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• IBS

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-10-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-10-30
• Last updated: 2013-10-01