Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT01717404
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
60 Years
Maximum Age:
70 Years
Study:
NCT01717404
Study Brief:
Protocol Section:
NCT01717404