Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With IBS-D

NCT ID: NCT02239926

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-09-30

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 diarrhea predominant IBS (IBS-D). The study will consist of a 2 week run in period, followed by 4 weeks of treatment period with oral ranolazine 1000 mg twice daily. Primary endpoint of the study will be the average Bowel Symptom Scale (BSS) scores for diarrhea and adequate relief of IBS pain and discomfort are secondary end points.

Conditions

Diarrhea Predominant Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ranolazine

tablet, 1000 mg twice daily for four weeks

Group Type: ACTIVE_COMPARATOR

Ranolazine

Intervention Type: DRUG

On January 31, 2006, ranolazine was approved for use in the United States by the Food and Drug Administration (FDA) for the treatment of chronic angina pectoris.

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Ranolazine

On January 31, 2006, ranolazine was approved for use in the United States by the Food and Drug Administration (FDA) for the treatment of chronic angina pectoris.

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Trade name Ranexa by Gilead Sciences.

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Yuri A. Saito Loftus

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuri A Saito, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

14-000581

Identifier Type: -

Identifier Source: org_study_id