Status:
TERMINATED
Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With IBS-D
Lead Sponsor:
Mayo Clinic
Conditions:
Diarrhea Predominant Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Will Ranolazine improve bowel function and abdominal pain in human subjects with IBS-D?
Detailed Description
This is a randomized double-blind placebo-controlled pilot study that will use validated bowel questionnaires to evaluate the effects of ranolazine administered orally twice daily in patients with dia...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Males and non-pregnant, non-breastfeeding females with established diagnosis of IBS-D by modified Rome III criteria (Abdominal Pain Intensity: weekly average of worst daily score of \>3.0 on a 0 to 10 point scale and Stool Consistency: at least one stool with a consistency of Type 5, 6 or 7 Bristol stool score on at least 2 days per week)
- 18-70 years old
- U.S. resident
- English-speaking (to provide consent and complete questionnaires)
- Exclusion Criteria
- Structural or metabolic diseases/conditions that affect the gastrointestinal system
- Unable to withdraw the following medications 48 hours prior to the study:
- Drugs that alter GI transit including Lomotil, and bile acid binders such as cholestyramine, prokinetics (e.g. metoclopramide, cisapride and erythromycin), narcotics (e.g. oxycodone, morphine) and anticholinergics (dicyclomine, hyoscyamine).
- Analgesic drugs including narcotics, NSAID, cyclooxygenase-2 ( COX2) inhibitors (celecoxib, rofecoxib, and valdecoxib)
- GABAergic agents (baclofen)
- Benzodiazepines (e.g. lorazepam, alprazolam, and diazepam). Low stable doses of thyroid replacement, estrogen replacement, and low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
- Unable to withdraw the following medications, which are contraindications of ranolazine:
- Strong Cytochrome P450, Family 3, Subfamily A (CYP3A) inhibitors (e.g. ketoconazole, clarithromycin, and nelfinavir)
- CYP3A inducers (e.g. rifampin, phenobarbital, St. John's wort)
- Female subjects who are pregnant or breastfeeding.
- Current symptoms of severe depression, as measured by Hospital Anxiety And Depression Scale ( HADS) score greater than 15.
- Clinical evidence (including physical exam, ECG, laboratory studies and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
- The Corrected QT Interval (QTc) \> 490 msec.
- Active alcoholics not in remission or known substance abusers.
- Liver cirrhosis
- Patients with clinically significant hepatic disease.
- Major cardiovascular events in the last 6 months.
- Participation in another clinical trial (within 30 days).
- Incarcerated.
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02239926
Start Date
September 1 2014
End Date
September 1 2015
Last Update
March 15 2016
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905