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

Overview

Will Ranolazine improve bowel function and abdominal pain in human subjects with IBS-D?

Full Title of Study: “Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 2015

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.

Interventions

  • Drug: 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.
  • Drug: Placebo

Arms, Groups and Cohorts

  • Active Comparator: Ranolazine
    • tablet, 1000 mg twice daily for four weeks
  • Placebo Comparator: Placebo
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Diarrhea Using the Bowel Symptom Score (BSS).
    • Time Frame: baseline to 4 weeks
    • BSS is a 100-mm visual analog scale for each symptom of Irritable Bowel Syndrome (IBS) (pain or discomfort, bloating, and diarrhea) with an overall severity score. Lower scores indicate symptoms are not present and higher scores indicate severe symptoms.

Secondary Measures

  • Mean Abdominal Pain
    • Time Frame: baseline to 4 weeks
    • Daily abdominal pain intensity was rated using an 11-point (0-10) numeric rating scale, with 0 being no pain, and 10 being the worst pain imaginable. Participants were asked to rate their worst abdominal pain over the past 24 hours.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yuri A. Saito Loftus, Associate Professor of Medicine – Mayo Clinic
  • Overall Official(s)
    • Yuri A Saito, MD,MPH, Principal Investigator, Mayo Clinic

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