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Low accrual and subject engagement
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | 500 mg tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Number of Loose Stools | Daily number of loose stools will be collected directly from all subjects using MyCap. | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Crohn's Disease Activity Index (CDAI) Score | The Crohn's Disease Activity Index (CDAI) combines weighted scores of clinical and laboratory variables to estimate disease severity. The CDAI consists of eight variables, two of which are subjective, related to the disease, each weighted according to its ability to be predictive of disease activity. The absolute score ranges from 0 to 600. CDAI scores of less than 150 indicate a clinical remission and scores over 450 indicate severely active disease. Since blood draws will not be performed as part of this study, the hematocrit component of the CDAI will not be assessed. |
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Inclusion Criteria:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Dawn B. Beaulieu, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
The investigators agree to the timely release and sharing of information to be no later than the acceptance for publication of the main findings from the final data set. Investigators are also committed to ensuring that all data are free of identifiers that would permit linkage to individual research participation as well as variables that could lead to deductive disclosure of individual subjects.
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4 of 4 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Ranolazine: 500 mg tablet Placebo: Ranolazine-matched placebo tablet |
| FG001 | 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 Ranolazine: 500 mg tablet Placebo: Ranolazine-matched placebo tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention:Baseline to 12 Weeks |
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| ||||||||||||||||||
| Second Intervention: 12 Weeks to 24 Week |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Ranolazine: 500 mg tablet Placebo: Ranolazine-matched placebo tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Daily Number of Loose Stools | Daily number of loose stools will be collected directly from all subjects using MyCap. | 1 subject in Placebo arm only has baseline data since they withdrew. | Posted | Mean | Standard Deviation | number of liquid stools | Baseline to 12 weeks |
|
Baseline to 24 weeks
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranolazine | - Participants receive a Ranolazine 500 mg tablet twice daily for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blurry vision | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael McGill | Vanderbilt University Medical Center | 615-322-4643 | michael.g.mcgill@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2022 | Jan 14, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 14, 2020 | Jan 14, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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
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| Placebo |
| Drug |
Ranolazine-matched placebo tablet |
|
| Baseline to 12 weeks |
| Harvey Bradshaw Index (HBI) Score | The Harvey-Bradshaw index (Harvey-Bradshaw Index - HBI) assesses the degree of illness (activity) in patients with Crohn's disease. The HBI consists of 5 items with a minimum score of 0 and a maximum attainable score depending on the number of stools the patient identifies per day. HBI scores < 5 are defined as clinical remission, HBI between 5 and 7 as mild disease, HBI between 8 and 16 as moderate disease, and HBI > 16 as severe disease. | Baseline to Week 12 |
| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | The SIBDQ is a 10-item questionnaire measuring quality of life in four domains: bowel symptoms, emotional health, systemic symptoms, and social function and is scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). The absolute score ranges are from 10 (poor Health-related quality of life) to 70 (optimum Health-related quality of life). | Baseline to 12 weeks |
| Patient Health Questionnaire (PHQ-9) Score | The PHQ-9 is a 9-item questionnaire that screens for the presence and severity of depression and can be used to make a depression diagnosis using DSM-IV criteria. The PHQ-9 is scored on a 3-point Likert scale from 0 (not at all) to 3 (nearly every day). The absolute score ranges are from 0 (none or minimal depression) to 27 (severe depression). | Baseline to week 12 |
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| BG001 | 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 Ranolazine: 500 mg tablet Placebo: Ranolazine-matched placebo tablet |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Crohn's Disease Activity Index (CDAI) Score | The Crohn's Disease Activity Index (CDAI) combines weighted scores of clinical and laboratory variables to estimate disease severity. The CDAI consists of eight variables, two of which are subjective, related to the disease, each weighted according to its ability to be predictive of disease activity. The absolute score ranges from 0 to 600. CDAI scores of less than 150 indicate a clinical remission and scores over 450 indicate severely active disease. Since blood draws will not be performed as part of this study, the hematocrit component of the CDAI will not be assessed. | One of three subjects on ranolazine did not have a baseline CDAI score. 1 of 4 subject on placebo did not complete course. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
|
|
|
| Secondary | Harvey Bradshaw Index (HBI) Score | The Harvey-Bradshaw index (Harvey-Bradshaw Index - HBI) assesses the degree of illness (activity) in patients with Crohn's disease. The HBI consists of 5 items with a minimum score of 0 and a maximum attainable score depending on the number of stools the patient identifies per day. HBI scores < 5 are defined as clinical remission, HBI between 5 and 7 as mild disease, HBI between 8 and 16 as moderate disease, and HBI > 16 as severe disease. | 1 of 4 subjects assigned placebo for 12 weeks did not complete course. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 12 |
|
|
|
| Secondary | Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | The SIBDQ is a 10-item questionnaire measuring quality of life in four domains: bowel symptoms, emotional health, systemic symptoms, and social function and is scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). The absolute score ranges are from 10 (poor Health-related quality of life) to 70 (optimum Health-related quality of life). | 1 of 4 subjects in placebo arm did not complete course. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12 weeks |
|
|
|
| Secondary | Patient Health Questionnaire (PHQ-9) Score | The PHQ-9 is a 9-item questionnaire that screens for the presence and severity of depression and can be used to make a depression diagnosis using DSM-IV criteria. The PHQ-9 is scored on a 3-point Likert scale from 0 (not at all) to 3 (nearly every day). The absolute score ranges are from 0 (none or minimal depression) to 27 (severe depression). | 1 of 4 subjects in placebo arm did not complete course. | Posted | Mean | Standard Deviation | score on a scale | Baseline to week 12 |
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Placebo | Participants receive a Placebo tablet (matching Ranolazine 500 mg tablets) twice daily for 12 weeks. | 0 | 4 | 0 | 4 | 1 | 4 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 12 week CDAI |
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| 12 week HBI |
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| Week 12 SIBDQ |
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| 12 week PHQ9 |
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