Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy

NCT04456517 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 200640
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

Diarrhea

Outcome Measures

Primary Outcomes (1)

• Daily Number of Loose Stools

  Daily number of loose stools will be collected directly from all subjects using MyCap.

  Baseline to 12 weeks

Secondary Outcomes (4)

• Crohn's Disease Activity Index (CDAI) Score

  Baseline to 12 weeks

• Harvey Bradshaw Index (HBI) Score

  Baseline to Week 12

• Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score

  Baseline to 12 weeks

• Patient Health Questionnaire (PHQ-9) Score

  Baseline to week 12

Study Arms (2)

Ranolazine, Then Placebo

EXPERIMENTAL

\- 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

Drug: Ranolazine; Drug: Placebo

Placebo, Then Ranolazine

EXPERIMENTAL

\- 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

Drug: Ranolazine; Drug: Placebo

Interventions

Ranolazine DRUG

500 mg tablet

Placebo, Then Ranolazine; Ranolazine, Then Placebo

Placebo DRUG

Ranolazine-matched placebo tablet

Placebo, Then Ranolazine; Ranolazine, Then Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Diarrhea

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Michael McGill
• Organization: Vanderbilt University Medical Center

michael.g.mcgill@vumc.org

615-322-4643

Study Officials

• Dawn B. Beaulieu, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Participants receive one of two alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: October 18, 2022
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: February 6, 2025
• Results First Posted: February 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)