Trial · NCT04456517
Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy
NCT04456517, Phase 2, Terminated, Vanderbilt University Medical Center; results first posted 2025-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy. Trials, record NCT04456517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04456517
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy
- NCT number
- NCT04456517
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Crohn's Disease, Inflammatory Bowel Disease
- Interventions
- Ranolazine, Placebo
- First posted
- 2020-07-02
- Last updated
- 2025-02-06
- Results first posted
- 2025-02-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Daily Number of Loose Stools | Baseline to 12 weeks | Daily number of loose stools will be collected directly from all subjects using MyCap. |
| Secondary | Crohn's Disease Activity Index (CDAI) Score | Baseline to 12 weeks | 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. |
| Secondary | Harvey Bradshaw Index (HBI) Score | Baseline to Week 12 | 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. |
| Secondary | Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | Baseline to 12 weeks | 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). |
| Secondary | Patient Health Questionnaire (PHQ-9) Score | Baseline to week 12 | 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). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Daily Number of Loose Stools | Baseline to 12 weeks | 1 subject in Placebo arm only has baseline data since they withdrew. | number of liquid stools | MEAN |
| SECONDARY | Crohn's Disease Activity Index (CDAI) Score | Baseline to 12 weeks | One of three subjects on ranolazine did not have a baseline CDAI score. 1 of 4 subject on placebo did not complete course. | score on a scale | MEAN |
| SECONDARY | Harvey Bradshaw Index (HBI) Score | Baseline to Week 12 | 1 of 4 subjects assigned placebo for 12 weeks did not complete course. | score on a scale | MEAN |
| SECONDARY | Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | Baseline to 12 weeks | 1 of 4 subjects in placebo arm did not complete course. | score on a scale | MEAN |
| SECONDARY | Patient Health Questionnaire (PHQ-9) Score | Baseline to week 12 | 1 of 4 subjects in placebo arm did not complete course. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Daily Number of Loose Stools | Ranolazine | Liquid Stools at Baseline | 3.6 | Standard Deviation 2.5 | number of liquid stools |
| Daily Number of Loose Stools | Placebo | Liquid Stools at Baseline | 4.5 | Standard Deviation 3.4 | number of liquid stools |
| Daily Number of Loose Stools | Ranolazine | Liquid stools at Week 12 | 2.9 | Standard Deviation 1.6 | number of liquid stools |
| Daily Number of Loose Stools | Placebo | Liquid stools at Week 12 | 3.2 | Standard Deviation 0.8 | number of liquid stools |
| Crohn's Disease Activity Index (CDAI) Score | Ranolazine | Baseline CDAI | 169 | Standard Deviation 90.5 | score on a scale |
| Crohn's Disease Activity Index (CDAI) Score | Placebo | Baseline CDAI | 117 | Standard Deviation 88.1 | score on a scale |
| Crohn's Disease Activity Index (CDAI) Score | Ranolazine | 12 week CDAI | 100 | Standard Deviation 99.6 | score on a scale |
| Crohn's Disease Activity Index (CDAI) Score | Placebo | 12 week CDAI | 110.3 | Standard Deviation 97.8 | score on a scale |
| Harvey Bradshaw Index (HBI) Score | Ranolazine | Baseline HBI | 6.7 | Standard Deviation 1.5 | score on a scale |
| Harvey Bradshaw Index (HBI) Score | Placebo | Baseline HBI | 5 | Standard Deviation 3.1 | score on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention:Baseline to 12 Weeks | STARTED | Ranolazine, Then Placebo | 3 | |
| First Intervention:Baseline to 12 Weeks | STARTED | Placebo, Then Ranolazine | 1 | |
| First Intervention:Baseline to 12 Weeks | COMPLETED | Ranolazine, Then Placebo | 3 | |
| First Intervention:Baseline to 12 Weeks | COMPLETED | Placebo, Then Ranolazine | 0 | |
| First Intervention:Baseline to 12 Weeks | NOT COMPLETED | Ranolazine, Then Placebo | 0 | |
| First Intervention:Baseline to 12 Weeks | NOT COMPLETED | Placebo, Then Ranolazine | 1 | |
| Second Intervention: 12 Weeks to 24 Week | STARTED | Ranolazine, Then Placebo | 3 | |
| Second Intervention: 12 Weeks to 24 Week | STARTED | Placebo, Then Ranolazine | 0 | |
| Second Intervention: 12 Weeks to 24 Week | COMPLETED | Ranolazine, Then Placebo | 3 | |
| Second Intervention: 12 Weeks to 24 Week | COMPLETED | Placebo, Then Ranolazine | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blurry vision | Eye disorders | Ranolazine | 0 | 3 | 0 |
| other | Blurry vision | Eye disorders | Placebo | 1 | 4 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranolazine | 0 | 3 |
| Total, all-cause mortality | Placebo | 0 | 4 |
| Total, other adverse events | Ranolazine | 0 | 3 |
| Total, other adverse events | Placebo | 1 | 4 |
| Total, serious adverse events | Ranolazine | 0 | 3 |
| Total, serious adverse events | Placebo | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ranolazine vs Placebo: deaths from any cause | Trial comparisons |
| Ranolazine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04456517
GET https://conductscience.org/api/trials/v1/NCT04456517/registered