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

Primary Purpose

Diarrhea Predominant Irritable Bowel Syndrome

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ranolazine
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea Predominant Irritable Bowel Syndrome focused on measuring IBS-D

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ranolazine

Placebo

Arm Description

tablet, 1000 mg twice daily for four weeks

Placebo

Outcomes

Primary Outcome Measures

Change From Baseline in Diarrhea Using the Bowel Symptom Score (BSS).
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 Outcome Measures

Mean Abdominal Pain
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.

Full Information

First Posted
September 11, 2014
Last Updated
February 16, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02239926
Brief Title
Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With IBS-D
Acronym
Ranolazine
Official Title
Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in enrolling subjects
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea Predominant Irritable Bowel Syndrome
Keywords
IBS-D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranolazine
Arm Type
Active Comparator
Arm Description
tablet, 1000 mg twice daily for four weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Trade name Ranexa by Gilead Sciences.
Intervention Description
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
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Diarrhea Using the Bowel Symptom Score (BSS).
Description
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.
Time Frame
baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Mean Abdominal Pain
Description
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.
Time Frame
baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuri A Saito, MD,MPH
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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

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