Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: September 30, 2013
Last verified: September 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: September 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
IBS

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Mexiletine
Anti-Arrhythmia Agents
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 25, 2014