NCT04456517

Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy

REACT Trial: A Randomized, Double Blind, Placebo-controlled, Crossover Study of Ranolazine for the Treatment of Crohn's Disease-associated Diarrhea

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Crohn's disease is an inflammatory disorder that can affect any part of the gastrointestinal (GI) tract. Some patients still experience persistent diarrhea or other symptoms such as abdominal pain even when their Crohn's disease is in remission. Diarrhea and/or abdominal pain that is not responsive to standard therapies can significantly affect a patient's quality of life and ability to work. The purpose of this study is to test the safety and effectiveness of the drug ranolazine in reducing Crohn's disease-associated diarrhea and other symptoms. Ranolazine is approved by the US Food \& Drug Administration (FDA) for chronic angina (a heart condition). This study is investigating if ranolazine could be used in the setting of Crohn's disease.

Conditions

• Crohn's Disease
• Inflammatory Bowel Disease

Interventions

Type	Name	Description
DRUG	Ranolazine	500 mg tablet
DRUG	Placebo	Ranolazine-matched placebo tablet

Timeline

• Start date: 2022-10-18
• Primary completion: 2024-04-11
• Completion: 2024-04-11
• First posted: 2020-07-02
• Last updated: 2025-02-06
• Results posted: 2025-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study