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

Diarrhea Predominant Irritable Bowel Syndrome Clinical Trial

— Ranolazine  

Official title:

Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02239926
• Other study ID #: 14-000581
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 11, 2014
• Last updated: February 16, 2016
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea Predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome

Intervention

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.
• Placebo

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline to 4 weeks	No
Secondary	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.	baseline to 4 weeks	No