Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy

NCT ID: NCT04456517

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2024-04-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ranolazine, Then Placebo

\- 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 Type: EXPERIMENTAL

Ranolazine

Intervention Type: DRUG

500 mg tablet

Placebo

Intervention Type: DRUG

Ranolazine-matched placebo tablet

Placebo, Then Ranolazine

\- 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

Group Type: EXPERIMENTAL

Ranolazine

Intervention Type: DRUG

500 mg tablet

Placebo

Intervention Type: DRUG

Ranolazine-matched placebo tablet

Interventions

Ranolazine

500 mg tablet

Intervention Type: DRUG

Placebo

Ranolazine-matched placebo tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Meet diagnostic criteria for Crohn's Disease with active diarrhea Either with active disease or in remission (as defined by endoscopic or radiographic findings) but experiencing symptoms (e.g., diarrhea, abdominal pain)
• Have greater than three loose stools per day

Exclusion Criteria

• Male and female subjects <18 years of age
• Significant change in medication including prednisone, antidepressant medications, or stimulants within the last 4 weeks

a. Allowances include: Rectal hydrocortisone, rectal mesalamine, addition of prednisone (up to 20mg) for flares, etc.

• Regular (daily) use of opioids or other drugs of abuse including heavy alcohol or marijuana use
• Severe psychiatric disease including schizophrenia, psychosis, suicidal depression
• Previous use of ranolazine within 2 months prior to enrollment
• Prior use of ranolazine which was discontinued for safety or tolerability
• Metabolic derangement defined as liver function tests >3x upper limit of normal or severe renal disease defined as calculated creatinine clearance <30 mL/min
• Have liver cirrhosis
• Concurrent use of CYP3A inhibitors, inducers, or substrates

a. These may include: ketoconazole, itraconazole, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir, clarithromycin, or rifampin, rifapentine, phenobarbital, phenytoin, and St. John's Wort, digoxin.

• A family history of (or congenital) long QT syndrome or known acquired QT interval prolongation
• Inability or refusal to give informed consent for any reason including a diagnosis of dementia or cognitive impairment
• Patients who are pregnant or breastfeeding
• Patients who are enrolled in other investigational drug studies or who have taken investigational drugs within 30 days before enrollment
• Other factors which in the opinion of the investigator could potentially impact the study outcomes (e.g., underlying disease, medications, history) or prevent the participant from completing the protocol (poor compliance or unpredictable schedule)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dawn Beaulieu

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn B. Beaulieu, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

200640

Identifier Type: -

Identifier Source: org_study_id