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Sodium Channel Blocker

Ranolazine for Crohn's Disease (REACT Trial)

Phase 2

Waitlist Available

Led By Dawn B. Beaulieu, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have greater than three loose stools per day

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 84, day 168

Awards & highlights

REACT Trial Summary

This trial is investigating whether ranolazine is effective and safe in reducing Crohn's disease-associated symptoms like diarrhea and abdominal pain.

Who is the study for?

This trial is for adults with Crohn's Disease who have frequent diarrhea (more than three loose stools per day), regardless of whether their disease is active or in remission. Participants should not have used ranolazine before, must not be on certain medications like statins or those affecting liver enzymes, and cannot be pregnant, breastfeeding, or using heavy drugs.Check my eligibility

What is being tested?

The study tests the effectiveness of ranolazine—a drug approved for chronic angina—in reducing diarrhea and abdominal pain associated with Crohn's Disease. It compares the outcomes between patients taking ranolazine and those given a placebo to see if it could be repurposed for Crohn's treatment.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include those commonly associated with ranolazine such as dizziness, headache, constipation or nausea. Since it affects heart rhythm, there might also be concerns about its impact on cardiac health.

REACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have more than three loose stools daily.

REACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 84, day 168

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 84, day 168

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 84, day 168 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change in daily number of loose stools from baseline

Secondary outcome measures

Mean change in Crohn's Disease Activity Index (CDAI) score

Mean change in Harvey Bradshaw Index (HBI) score

Patient Health Questionnaire (PHQ-9) score

+1 more

Side effects data

From 2015 Phase 4 trial • 31 Patients • NCT02052011

14%

Dizziness

100%

80%

60%

40%

20%

Study treatment Arm

Intervention Group

Placebo Control

REACT Trial Design

2Treatment groups

Experimental Treatment

Group I: Ranolazine, Then PlaceboExperimental Treatment2 Interventions

- Participants first receive a Ranolazine 500 mg tablet twice daily for 12 weeks, they then receive a Placebo tablet (matching Ranolazine 500 mg tablets) twice daily for 12 weeks. This treatment will be given to participants with either active CD or patients with CD that is in remission but who experience continued symptoms

Group II: Placebo, Then RanolazineExperimental Treatment2 Interventions

- Participants first receive a Placebo tablet (matching Ranolazine 500 mg tablets) twice daily for 12 weeks, they then receive a Ranolazine 500mg tablet twice daily for 12 weeks. This treatment will be given to participants with either active CD or patients with CD that is in remission but who experience continued symptoms

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ranolazine

2014

Completed Phase 4

~11570

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

672,176 Total Patients Enrolled

Dawn B. Beaulieu, MDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Ranolazine (Sodium Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04456517 — Phase 2

Crohn's Disease Research Study Groups: Placebo, Then Ranolazine, Ranolazine, Then Placebo

Crohn's Disease Clinical Trial 2023: Ranolazine Highlights & Side Effects. Trial Name: NCT04456517 — Phase 2

Ranolazine (Sodium Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04456517 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the research history of Ranolazine?

"There are two ongoing clinical trials for Ranolazine that have not reached Phase 3 and both are based in Albuquerque, New mexico."

Answered by AI

Could you explain the risks associated with taking Ranolazine?

"While there is some evidence to support the safety of Ranolazine, as this is a Phase 2 trial, none of the data collected thus far supports its efficacy. Consequently, it received a score of 2."

Answered by AI

How many people are eligible to participate in this clinical trial?

"As of right now, this study is not recruiting patients. The clinical trial was first advertised on October 18th, 2020 and the listing was last updated 3 days ago. There are 434 other trials targeting ileocolitis patients and 2 Ranolazine studies that are actively enrolling participants."

Answered by AI

What is unique about this clinical trial?

"Ranolazine has been studied in 2 trials, both of which are active. The first study was conducted in 2012 and sponsored by Gilead Sciences. Only 20 participants were involved in the trial, which completed its N/A drug approval stage. In total, 18313 studies have been completed since 2012."

Answered by AI

Are there any available slots for new participants in this trial?

"According to the latest information available on clinicaltrials.gov, this particular trial is not currently looking for participants. The study was initially posted on 10/18/2022 but has not been updated since 10/21/2022. Although this specific trial is no longer enrolling patients, there are 436 other trials that are presently recruiting individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy

Dawn Beaulieu 2022. "Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04456517.

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