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

NCT02239926 | Terminated Phase 2 Results

• 1 other identifier: 14-000581
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diarrhea Predominant Irritable Bowel Syndrome

Keywords

IBS-D

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Mean Abdominal Pain

  baseline to 4 weeks

Study Arms (2)

Ranolazine

ACTIVE COMPARATOR

tablet, 1000 mg twice daily for four weeks

Drug: Ranolazine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Ranolazine 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.

Also known as: Trade name Ranexa by Gilead Sciences.

Ranolazine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years old
• U.S. resident
• English-speaking (to provide consent and complete questionnaires)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Ranolazine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was terminated early due to enrollment issues.

Results Point of Contact

• Title: Dr. Yuri Saito Loftus
• Organization: Mayo Clinic

saito.yuri@mayo.edu

507-255-3680

Study Officials

• Yuri A Saito, MD,MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 11, 2014
• First Posted: September 15, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 15, 2016
• Results First Posted: February 8, 2016

Record last verified: 2016-02

Locations

US (1)